Screw, Fixation, Bone
Locking screw, self-tapping, ø 4.9 mm, 100 mm
31manufacturers in China registered for this device type
1,993catalogue numbers in this listing
12510(k) clearances naming this product code
40recalls on this code
Who Else Makes It
Concentrated in Jiangsu (15), Shanghai (5), Zhejiang (3). 19 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
Showing 12 of 31. All 31 manufacturers in China registered for Screw, Fixation, Bone
Record
| Listed by | Zimmer, Inc., United States |
|---|---|
| FDA product code | HWC |
| Device type | Screw, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K050121 |
| Record published | 2017-09-28 |
| Record revised | 2025-11-20 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Length 6 to 349 mm; outer diameter 0.7 to 7.5 mm; height 1.5 to 2 mm; lumen/inner diameter 2.7 mm |
| Distribution end date | 2021-12-02 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 47-2357-009-18 | Length 237 mm | In distribution | |
| 47-2347-020-22 | 3.5 mm, Diameter | In distribution | |
| 47-2347-024-60 | Length 60 mm | In distribution | |
| 47-2369-050-27 | Length 50 mm | In distribution | |
| 47-4640-018-00 | Length 18 mm | In distribution | |
| 4835-100-01 | 3.5 mm Cortical Screw | In distribution | |
| 2480-30-40 | Length 30.00 mm | In distribution | |
| 47-4640-020-00 | 4.0 mm, Cancellous Screw | In distribution | |
| 4827-70-01 | 2.7 mm Cortical Screw | In distribution | |
| 00-4828-040-02 | Length 40 mm | In distribution | |
| 4820-40 | Length 40 mm | In distribution | |
| 4845-14-01 | Length 14 mm | In distribution | |
| 28.22.034 | Outer Diameter 3.5 mm | In distribution | |
| 2347-20-85 | Length 85 mm | In distribution | |
| 28.01.010 | Sys 3.5 | In distribution | |
| 4815-10-02 | Length 10 mm | In distribution | |
| 4845-40-08 | Length 40 mm | In distribution | |
| 4835-130-07 | 3.5 mm Pelvic Cortical Screw | In distribution | |
| 1150-18 | 2.5 mm, Leading, 3.2 mm Trailing Thread, Diameter | In distribution | |
| 47-4935-034-01 | Length 34 mm | In distribution | |
| 00-2369-048-35 | Length 48 mm | In distribution | |
| 00-2369-075-35 | 3.5 mm Locking Screw | In distribution | |
| 47-2347-120-00 | Length 100 mm | In distribution | |
| 4840-80-01 | 4.0 mm Cancellous Screw | In distribution | |
| 4835-110-01 | 3.5 mm Cortical Screw | In distribution | |
| 00-2369-008-27 | 2.7 mm Locking Screw | In distribution | |
| 47-4820-032-00 | 2.0 mm, Cortical Screw | In distribution | |
| 4815-18-02 | Length 18 mm | In distribution | |
| 47-2369-042-35 | Length 42 mm | In distribution | |
| 47-2347-025-90 | Length 90 mm | In distribution | |
| 4835-65 | Length 65 mm | In distribution | |
| 28.24.032 | Outer Diameter 4.5 mm | In distribution | |
| 2480-24-41 | 4.0 mm Diameter | In distribution | |
| 4815-12 | 1.5 mm Cortical Screw | In distribution | |
| 28.80.030 | Outer Diameter 4.5 mm | In distribution | |
| 47-2359-026-35 | 3.5 mm, Locking Screw | In distribution | |
| 28.24.126 | Outer Diameter 4.5 mm | In distribution | |
| 2359-42-27 | 2.7 mm Locking Screw | In distribution | |
| 47-1154-24 | 3.0 mm Lead.Thr.Diameter, 4.0 mm Trail.Thr.Diameter, 3.0 mm, Diameter | In distribution | |
| 00-2369-060-27 | 2.7 mm Locking Screw | In distribution | |
| 2347-20-65 | Length 65 mm | In distribution | |
| 2347-125-50 | (32 mm Thread Length), 6.5 mm Diameter | In distribution | |
| 4840-65-01 | Length 65 mm | In distribution | |
| 47-2359-038-35 | 3.5 mm, Locking Screw | In distribution | |
| 4835-36-01 | Length 36 mm | In distribution | |
| 4845-70-08 | Length 70 mm | In distribution | |
| 00-4627-046-01 | Length 46 mm | In distribution | |
| 47-2347-120-20 | 3.5 mm, Diameter | In distribution | |
| 47-4627-016-01 | Length 16 mm | In distribution | |
| 4820-44 | 2.0 mm Cortical Screw | In distribution | |
| 47-2347-126-00 | 6.5 mm, Diameter | In distribution | |
| 4840-90-01 | 4.0 mm Cancellous Screw | In distribution | |
| 4845-130 | 4.5 mm Cortical Screw | In distribution | |
| 4865-150-02 | 6.5 mm Cancellous Screw, 32 mm Thread Length | In distribution | |
| 47-2347-021-30 | 4.0 mm, Diameter | In distribution | |
| 4827-26 | 2.7 mm Cortical Screw | In distribution | |
| 4827-14 | 2.7 mm Cortical Screw | In distribution | |
| 47-2347-023-48 | 4.5 mm, Diameter | In distribution | |
| 00-2359-070-38 | Length 70 mm | In distribution | |
| 47-1155-60-05 | 4.5 mm, Diameter | In distribution | |
| 47-2359-060-27 | 2.7 mm, Locking Screw | In distribution | |
| 4301-07-070 | Length 70 mm | In distribution | |
| 47-2357-018-08 | Length 132 mm | In distribution | |
| 00-4640-040-00 | 4.0 mm Cancellous Screw | In distribution | |
| 47-2347-021-45 | 4.0 mm, Diameter | In distribution | |
| 47-2357-003-06 | Length 104 mm | In distribution | |
| 47-2348-105-35 | 3.5 mm, Diameter | In distribution | |
| 4835-100-07 | 3.5 mm Pelvic Cortical Screw | In distribution | |
| 47-2347-125-05 | 32 mm Thread Length, 6.5 mm, Diameter | In distribution | |
| 47-4827-026-00 | Length 26 mm | In distribution | |
| 4835-30-04 | 3.5 mm Shaft Screw | In distribution | |
| 35.18.008 | Outer Diameter 1.8 mm | In distribution | |
| 47-2347-125-45 | 32 mm Thread Length, 6.5 mm Diameter | In distribution | |
| 47-4827-070-01 | 2.7 mm, Cortical Screw | In distribution | |
| 4835-30-01 | 3.5 mm Cortical Screw | In distribution | |
| 00-2359-014-26 | 2.7 mm Conical Screw | In distribution | |
| 4827-40-01 | Length 40 mm | In distribution | |
| 4845-64-01 | 4.5 mm Cortical Screw | In distribution | |
| 47-4640-026-00 | 4.0 mm, Cancellous Screw | In distribution | |
| 2359-48-27 | 2.7 mm Locking Screw | In distribution | |
| 2347-126-40 | 6.5 mm Diameter | In distribution | |
| 4820-08 | 2.0 mm Cortical Screw | In distribution | |
| 6500-07-058 | Length 58 mm | In distribution | |
| 47-4820-036-02 | Length 36 mm | In distribution | |
| 2359-20-25 | 2.4 mm Conical Screw | In distribution | |
| 4840-60-01 | 4.0 mm Cancellous Screw | In distribution | |
| 47-2347-026-35 | 6.5 mm, Diameter | In distribution | |
| 47-2347-020-18 | Length 18 mm | In distribution | |
| 28.30.020 | Length 20 mm | In distribution | |
| 2348-58-35 | 3.5 mm Diameter | In distribution | |
| 47-2357-017-08 | Length 132 mm | In distribution | |
| 47-4936-003-03 | Length 42 mm | In distribution | |
| 4835-26-01 | Length 26 mm | In distribution | |
| 47-2348-080-35 | Length 80 mm | In distribution | |
| 2347-123-05 | 4.5 mm Diameter | In distribution | |
| 47-2347-124-20 | Length 120 mm | In distribution | |
| 4845-120-01 | 4.5 mm Cortical Screw | In distribution | |
| 2347-123-25 | Length 125 mm | In distribution | |
| 1150-24 | Length 24 mm | In distribution | |
| 28.22.016 | Length 16 mm | In distribution | |
| 47-2347-120-25 | 3.5 mm, Diameter | In distribution | |
| 4835-120-07 | 3.5 mm Pelvic Cortical Screw | In distribution | |
| 2348-42-35 | 3.5 mm Diameter | In distribution | |
| 47-2359-085-56 | Length 85 mm | In distribution | |
| 00-4640-018-01 | Length 18 mm | In distribution | |
| 4865-20 | 6.5 mm Cancellous Screw | In distribution | |
| 47-2347-123-25 | Length 125 mm | In distribution | |
| 47-2347-025-45 | Length 45 mm | In distribution | |
| 47-2348-024-35 | 3.5 mm, Diameter | In distribution | |
| 4820-06-02 | 2.0 mm Cortical Screw | In distribution | |
| 47-2358-002-06 | Length 114 mm | In distribution | |
| 00-2369-090-35 | 3.5 mm Locking Screw | In distribution | |
| 47-2348-095-35 | Length 95 mm | In distribution | |
| 00-2369-044-35 | Length 44 mm | In distribution | |
| 4820-10 | Length 10 mm | In distribution | |
| 00-4828-060-02 | Length 60 mm | In distribution | |
| 47-4845-100-01 | Length 100 mm | In distribution | |
| 47-2347-020-75 | Length 75 mm | In distribution | |
| 2347-120-20 | 3.5 mm Diameter | In distribution | |
| 4845-26-01 | 4.5 mm Cortical Screw | In distribution | |
| 28.22.060 | Length 60 mm | In distribution | |
| 00-4936-005-03 | 5 Holes | In distribution | |
| 28.25.120 | Outer Diameter 2.7 mm | In distribution | |
| 4865-130 | 6.5 mm Cancellous Screw | In distribution | |
| 02.03149.046 | Outer Diameter 4.9 mm | In distribution | |
| 4840-28 | Length 28 mm | In distribution | |
| 47-4936-004-13 | 3.5 mm Locking Reconstruction Plate, 4 Holes | In distribution | |
| 4820-50 | Length 50 mm | In distribution | |
| 00-4935-060-01 | 3.5 mm Cortical Screw | In distribution | |
| 47-4935-020-01 | 3.5 mm, Cortical Screw | In distribution | |
| 47-2369-026-35 | Length 26 mm | In distribution | |
| 2358-28-03 | Length 34 mm | In distribution | |
| 28.01.001N | 1mm step, Sys 3.5 | In distribution | |
| 4845-30-01 | 4.5 mm Cortical Screw | In distribution | |
| 4820-42 | Length 42 mm | In distribution | |
| 47-2347-022-32 | 4.0 mm, Diameter | In distribution | |
| 47-2369-040-27 | 2.7 mm, Locking Screw | In distribution | |
| 47-4935-065-01 | 3.5 mm, Cortical Screw | In distribution | |
| 4840-16-01 | 4.0 mm Cancellous Screw | In distribution | |
| 4845-155-01 | Length 155 mm | In distribution | |
| 4840-16 | Length 16 mm | In distribution | |
| 4820-34 | 2.0 mm Cortical Screw | In distribution | |
| 00-4627-038-01 | 2.7 mm Cortical Screw | In distribution | |
| 28.20.030 | Outer Diameter 3.5 mm | In distribution | |
| 4865-120-01 | 6.5 mm Cancellous Screw, 16 mm Thread Length | In distribution | |
| 47-1154-26 | Length 26 mm | In distribution | |
| 2347-24-45 | 6.5 mm Diameter | In distribution | |
| 4835-70 | Length 70 mm | In distribution | |
| 2347-22-12 | Length 12 mm | In distribution | |
| 4827-55 | 2.7 mm Cortical Screw | In distribution | |
| 2359-26-24 | 2.4 mm Locking Screw | In distribution | |
| 00-4640-014-01 | Length 14 mm | In distribution | |
| 47-1155-45-07 | Length 45 mm | In distribution | |
| 47-2357-004-08 | Length 128 mm | In distribution | |
| 2347-25-45 | 6.5 mm Diameter | In distribution | |
| 4845-105-01 | 4.5 mm Cortical Screw | In distribution | |
| 47-2369-046-35 | 3.5 mm, Locking Screw | In distribution | |
| 2359-24-35 | 3.5 mm Locking Screw | In distribution | |
| 47-2347-022-26 | Length 26 mm | In distribution | |
| 4820-24 | Length 24 mm | In distribution | |
| 28.24.128 | Outer Diameter 4.5 mm | In distribution | |
| 28.07.105 | 5-hole, T-shape, Sys 2.7 | In distribution | |
| 28.44.100 | Length 100 mm | In distribution | |
| 2347-20-60 | Length 60 mm | In distribution | |
| 4840-65 | Length 65 mm | In distribution | |
| 2348-46-35 | Length 46 mm | In distribution | |
| 2347-120-30 | Length 130 mm | In distribution | |
| 2348-40-35 | Length 40 mm | In distribution | |
| 47-4627-036-01 | Length 36 mm | In distribution | |
| 605202150 | Outer Diameter 2.0 mm | 10 | In distribution |
| 47-2359-055-45 | Length 55 mm | In distribution | |
| 28.25.114 | TX8 | In distribution | |
| 4840-24 | Length 24 mm | In distribution | |
| 2359-30-24 | 2.4 mm Locking Screw | In distribution | |
| 47-2359-028-27 | Length 28 mm | In distribution | |
| 28.07.208 | 8-hole, T-shape, left, Sys 2.7 | In distribution | |
| 2347-124-40 | (16 mm Thread Length), 6.5 mm Diameter | In distribution | |
| 2348-70-35 | 3.5 mm Diameter | In distribution | |
| 00-2369-018-35 | Length 18 mm | In distribution | |
| 00-4828-020-02 | Length 20 mm | In distribution | |
| 47-1155-25-07 | 6.5 mm, Diameter | In distribution | |
| 2348-100-35 | Length 100 mm | In distribution | |
| 2359-08-25 | Length 8 mm | In distribution | |
| 00-2369-028-27 | Length 28 mm | In distribution | |
| 4820-46 | 2.0 mm Cortical Screw | In distribution | |
| 47-2359-038-24 | Length 38 mm | In distribution | |
| 47-4828-046-02 | 2.7 mm, Locking Screw | In distribution | |
| 2359-60-56 | Length 60 mm | In distribution | |
| 4840-75 | Length 75 mm | In distribution | |
| 47-1154-18 | 3.0 mm Lead.Thr.Diameter, 4.0 mm Trail.Thr.Diameter, 3.0 mm, Diameter | In distribution | |
| 47-2347-020-46 | Length 46 mm | In distribution | |
| 47-2359-030-35 | Length 30 mm | In distribution | |
| 28.24.030 | TX10 | In distribution | |
| 47-2359-044-35 | Length 44 mm | In distribution | |
| 47-4815-010-00 | Length 10 mm | In distribution | |
| 47-4640-032-00 | Length 32 mm | In distribution | |
| 4840-50 | Length 50 mm | In distribution | |
| 4840-14-01 | 4.0 mm Cancellous Screw | In distribution | |
| 47-1155-75-05 | 4.5 mm, Diameter | In distribution | |
| 47-2347-125-15 | 32 mm Thread Length, 6.5 mm, Diameter | In distribution | |
| 47-4820-008-02 | 2.0 mm, Cortical Screw | In distribution | |
| 47-1155-80-07 | Length 80 mm | In distribution | |
| 00-2369-024-35 | 3.5 mm Locking Screw | In distribution | |
| 4820-48 | Length 48 mm | In distribution | |
| 28.25.124 | Outer Diameter 2.7 mm | In distribution | |
| 4820-12-02 | 2.0 mm Cortical Screw | In distribution | |
| 4835-110-07 | 3.5 mm Pelvic Cortical Screw | In distribution | |
| 47-4820-046-00 | 2.0 mm, Cortical Screw | In distribution | |
| 28.22.036 | Length 36 mm | In distribution | |
| 47-4640-032-01 | 4.0 mm, Cancellous Screw | In distribution | |
| 4835-32 | Length 32 mm | In distribution | |
| 4845-36-01 | 4.5 mm Cortical Screw | In distribution | |
| 47-2359-044-38 | Length 44 mm | In distribution | |
| 28.20.135 | HEX | In distribution | |
| 2359-36-25 | Length 36 mm | In distribution | |
| 2359-18-35 | 3.5 mm Locking Screw | In distribution | |
| 4301-07-025 | Length 25 mm | In distribution | |
| 4845-58 | 4.5 mm Cortical Screw | In distribution | |
| 47-1155-75-07 | Length 75 mm | In distribution | |
| 4865-135 | 6.5 mm Cancellous Screw | In distribution | |
| 4835-26-04 | 3.5 mm Shaft Screw | In distribution | |
| 00-2369-016-35 | 3.5 mm Locking Screw | In distribution | |
| 4865-75 | 6.5 mm Cancellous Screw | In distribution | |
| 47-2347-023-65 | 4.5 mm, Diameter | In distribution | |
| 35.23.022 | TX6 | In distribution | |
| 2347-23-44 | Length 44 mm | In distribution | |
| 2359-14-27 | 2.7 mm Locking Screw | In distribution | |
| 4845-76-04 | Length 76 mm | In distribution | |
| 47-4820-040-01 | 2.0 mm, Cortical Screw | In distribution | |
| 28.20.140 | HEX | In distribution | |
| 00-4640-030-00 | Length 30 mm | In distribution | |
| 4827-16 | Length 16 mm | In distribution | |
| 2347-126-45 | Length 145 mm | In distribution | |
| 47-4935-050-01 | Length 50 mm | In distribution | |
| 47-2348-046-35 | 3.5 mm, Diameter | In distribution | |
| 47-4640-034-01 | 4.0 mm, Cancellous Screw | In distribution | |
| 28.24.038 | Length 38 mm | In distribution | |
| 2359-14-24 | Length 14 mm | In distribution | |
| 47-1154-14 | Length 14 mm | In distribution | |
| 47-2369-085-35 | 3.5 mm, Locking Screw | In distribution | |
| 4865-105 | Length 105 mm | In distribution | |
| 47-1155-055-07 | 6.5 mm, Diameter | In distribution | |
| 47-4827-020-01 | 2.7 mm, Cortical Screw | In distribution | |
| 2347-20-80 | Length 80 mm | In distribution | |
| 2347-120-25 | 3.5 mm Diameter | In distribution | |
| 47-2347-023-70 | Length 70 mm | In distribution | |
| 2348-44-35 | 3.5 mm Diameter | In distribution | |
| 2347-124-20 | (16 mm Thread Length), 6.5 mm Diameter | In distribution | |
| 2347-26-75 | Length 75 mm | In distribution | |
| 47-4936-006-07 | 3.5 mm, 6 Holes | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Screw, Fixation, Bone | Synthes Gmbh | 3,975 |
| Aptus | Medartis Inc. | 3,623 |
| Acumed | Acumed LLC | 3,187 |
| Arthrex® | Arthrex, Inc. | 2,781 |
| OsteoMed | Osteomed | 2,764 |
| Screw, Fixation, Bone | AAP Implantate AG | 2,176 |
| Arix System Bone Screw | Jeil Medical Corporation | 1,875 |
| Cannulated Screw System + | Tyber Medical | 1,814 |
| Cannulated Compression Headless Screw | Tyber Medical | 1,621 |
| Microware Bone Plates and Bone Screws | Microware Precision Co., Ltd. | 1,601 |
| Anthem | Globus Medical, Inc. | 1,538 |
| Volt | Synthes Gmbh | 1,444 |
Showing 12 of 5,775. All products under Screw, Fixation, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K152841 | 2015-11-24 |
| K143165 | 2015-03-31 |
| K142442 | 2014-10-03 |
| K130810 | 2013-09-19 |
| K112885 | 2011-12-19 |
| K111447 | 2011-10-05 |
| K101696 | 2010-09-10 |
| K070906 | 2007-05-01 |
| K060710 | 2006-04-26 |
| K051098 | 2005-07-07 |
| K946347 | 1995-07-11 |
| K792022 | 1979-10-26 |
Recalls Naming This Product
87 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Zimmer, Inc. | 510(k) number | 2024-03-20 | Class II | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in s | ||
| Zimmer, Inc. | 510(k) number | 2024-03-20 | Class II | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in s | ||
| Zimmer, Inc. | 510(k) number | 2024-03-20 | Class II | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in s | ||
| Zimmer, Inc. | 510(k) number | 2024-03-20 | Class II | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in s | ||
| Zimmer, Inc. | 510(k) number | 2024-03-20 | Class II | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in s | ||
| Zimmer, Inc. | 510(k) number | 2024-03-20 | Class II | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in s | ||
| Zimmer, Inc. | 510(k) number | 2024-03-20 | Class II | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in s | ||
| Zimmer, Inc. | 510(k) number | 2024-03-20 | Class II | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in s | ||
| Zimmer, Inc. | 510(k) number | 2024-03-20 | Class II | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in s | ||
| Zimmer, Inc. | 510(k) number | 2024-03-20 | Class II | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in s | ||
| Zimmer, Inc. | 510(k) number | 2024-03-20 | Class II | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in s | ||
| Zimmer, Inc. | 510(k) number | 2024-03-20 | Class II | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in s | ||
| Zimmer, Inc. | 510(k) number | 2024-03-20 | Class II | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in s | ||
| Zimmer, Inc. | 510(k) number | 2024-03-20 | Class II | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in s | ||
| Zimmer, Inc. | 510(k) number | 2024-03-20 | Class II | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in s | ||
| Zimmer, Inc. | 510(k) number | 2024-03-20 | Class II | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in s | ||
| Zimmer, Inc. | 510(k) number | 2024-03-20 | Class II | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in s | ||
| Zimmer, Inc. | 510(k) number | 2024-03-20 | Class II | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in s | ||
| Zimmer, Inc. | 510(k) number | 2024-03-20 | Class II | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in s | ||
| Zimmer, Inc. | 510(k) number | 2024-03-20 | Class II | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in s | ||
| Zimmer, Inc. | 510(k) number | 2024-03-20 | Class II | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in s | ||
| Zimmer, Inc. | 510(k) number | 2023-06-27 | Class II | Process control | Thread form issue of the locking holes in that the locking screws would not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock. | 75 units | |
| Zimmer, Inc. | 510(k) number | 2019-10-10 | Class II | Packaging change control | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 5,459,583 total devices | 2020-05-19 |
| Zimmer, Inc. | 510(k) number | 2019-10-10 | Class II | Packaging change control | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 5,459,583 total devices | 2020-05-19 |
| Zimmer, Inc. | 510(k) number | 2019-10-10 | Class II | Packaging change control | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 5,459,583 total devices | 2020-05-19 |
| Zimmer, Inc. | 510(k) number | 2019-10-10 | Class II | Packaging change control | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 5,459,583 total devices | 2020-05-19 |
| Zimmer, Inc. | 510(k) number | 2019-10-10 | Class II | Packaging change control | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 5,459,583 total devices | 2020-05-19 |
| Zimmer, Inc. | 510(k) number | 2019-10-10 | Class II | Packaging change control | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 5,459,583 total devices | 2020-05-19 |
| Zimmer, Inc. | 510(k) number | 2019-10-10 | Class II | Packaging change control | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 5,459,583 total devices | 2020-05-19 |
| Zimmer, Inc. | 510(k) number | 2019-10-10 | Class II | Packaging change control | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 5,459,583 total devices | 2020-05-19 |
| Zimmer, Inc. | 510(k) number | 2019-10-10 | Class II | Packaging change control | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 5,459,583 total devices | 2020-05-19 |
| Zimmer Manufacturing B.V. | 510(k) number | 2016-05-04 | Class II | Packaging change control | A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. | 794 | 2017-07-05 |
| Zimmer Manufacturing B.V. | 510(k) number | 2016-05-04 | Class II | Packaging change control | A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. | 100 | 2017-07-05 |
| Zimmer Manufacturing B.V. | 510(k) number | 2016-05-04 | Class II | Packaging change control | A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. | 200 | 2017-07-05 |
| Zimmer Manufacturing B.V. | 510(k) number | 2016-05-04 | Class II | Packaging change control | A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. | 99 | 2017-07-05 |
| Zimmer Manufacturing B.V. | 510(k) number | 2016-05-04 | Class II | Packaging change control | A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. | 3955 | 2017-07-05 |
| Zimmer Manufacturing B.V. | 510(k) number | 2016-05-04 | Class II | Packaging change control | A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. | 90 | 2017-07-05 |
| Zimmer Manufacturing B.V. | 510(k) number | 2016-05-04 | Class II | Packaging change control | A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. | 3893 | 2017-07-05 |
| Zimmer Manufacturing B.V. | 510(k) number | 2016-01-11 | Class II | Packaging | As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. The affected products are sterile. | 154 | 2017-04-13 |
| Zimmer Manufacturing B.V. | 510(k) number | 2016-01-11 | Class II | Packaging | As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. The affected products are sterile. | 60 | 2017-04-13 |
Showing 40 of 87.
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2013-10-11 | Class II | Packaging | Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building | 7,044,680 total | 2017-04-14 |
| 2013-10-11 | Class II | Packaging | Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building | 7,044,680 total | 2017-04-14 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.