V-TEK™
36 catalogue numbers from 28.10.201, listed by Zimmer, Inc., United States, under Screw, Fixation, Bone. 31 manufacturers in China are registered for this product code.
31manufacturers in China registered for this device type
36catalogue 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) | K152312 |
| Record published | 2017-01-06 |
| Record revised | 2024-02-19 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Length 8 to 124 mm; outer diameter 2 to 4.5 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 28.10.201 | 2mm Offset, straight, Sys 3.5 | In distribution |
| 28.25.410 | Length 10 mm | In distribution |
| 28.25.412 | Length 12 mm | In distribution |
| 28.20.410 | Length 10 mm | In distribution |
| 28.25.416 | Length 16 mm | In distribution |
| 28.25.418 | Length 18 mm | In distribution |
| 28.65.116 | Outer Diameter 2 mm | In distribution |
| 28.65.120 | Outer Diameter 2 mm | In distribution |
| 28.10.019 | for plates XS/S, Sys 2.7 | In distribution |
| 28.10.005 | M, Sys 2.7 | In distribution |
| 502015638 | Length 124 mm | In distribution |
| 28.65.110 | Outer Diameter 2 mm | In distribution |
| 28.65.510 | TX8 | In distribution |
| 28.10.007 | L, Sys 2.7 | In distribution |
| 28.65.012 | Length 12 mm | In distribution |
| 28.10.107 | 0mm Offset, S, L-shape, right, Sys 2.7 | In distribution |
| 28.10.122 | for plates Sys 3.5 | In distribution |
| 28.65.508 | Outer Diameter 4.5 mm | In distribution |
| 28.10.315 | 5mm Offset, L, Sys 2.7/3.5 | In distribution |
| 28.10.310 | 0mm Offset, L, Sys 2.7/3.5 | In distribution |
| 28.65.026 | Outer Diameter 3 mm | In distribution |
| 28.10.022 | for plates Sys 2.7 | In distribution |
| 28.65.022 | Outer Diameter 3 mm | In distribution |
| 28.65.016 | Length 16 mm | In distribution |
| 28.65.118 | Outer Diameter 2 mm | In distribution |
| 28.10.130 | for plates, S, L-shape, Sys.2.7 | In distribution |
| 28.10.003 | S, Sys 2.7 | In distribution |
| 28.25.414 | Length 14 mm | In distribution |
| 28.10.109 | 2mm Offset, S, L-shape, right, Sys 2.7 | In distribution |
| 28.25.408 | TX8 | In distribution |
| 28.10.015 | for plates M/L, Sys 2.7 | In distribution |
| 28.65.114 | Length 14 mm | In distribution |
| 28.65.112N | Length 12 mm | In distribution |
| 28.65.514 | Length 14 mm | In distribution |
| 28.10.016 | for plates M/L, Sys 2.7, AO | In distribution |
| 28.10.028 | for Offset, L, Sys 2.7/3.5, curved | In distribution |
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 |
| Screw, Fixation, Bone | Zimmer, Inc. | 1,993 |
| 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 |
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
40 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 |
|---|---|---|---|---|---|
| 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 | ||
| 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 | ||
| 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 | ||
| 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 | ||
| 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 | ||
| 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 | ||
| 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 | ||
| 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 | ||
| 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 | ||
| 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 | ||
| 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 | ||
| 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 | ||
| 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 | ||
| 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 | ||
| 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 | ||
| 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 | ||
| 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 | ||
| 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 | ||
| 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 | ||
| 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 | ||
| 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 | ||
| 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 |
| 2015-12-09 | Class II | Labeling Change Control | Product on the package label did not match what was inside the package. The label was for part number 00-2359-058-35 (Zimmer Periarticular Locking Plate System 3.5mm Locking Screw 58mm Length) lot number 62918019 while the product inside | 400 | 2016-11-08 |
| 2014-07-22 | Class II | Package design/selection | Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only. | 47,682 units total | 2015-06-18 |
| 2014-07-22 | Class II | Package design/selection | Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, multiple test samples from each of the six configurations faile | 972,125 units | 2015-09-15 |
| 2014-07-22 | Class II | Package design/selection | Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only. | 47,682 units total | 2015-06-18 |
| 2014-07-22 | Class II | Package design/selection | Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only. | 47,682 units total | 2015-06-18 |
| 2014-07-22 | Class II | Package design/selection | Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only. | 47,682 units total | 2015-06-18 |
| 2014-07-22 | Class II | Package design/selection | Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only. | 47,682 units total | 2015-06-18 |
| 2014-07-22 | Class II | Package design/selection | Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only. | 47,682 units total | 2015-06-18 |
| 2014-07-22 | Class II | Package design/selection | Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only. | 47,682 units total | 2015-06-18 |
| 2014-07-22 | Class II | Package design/selection | Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only. | 47,682 units total | 2015-06-18 |
| 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 |
| 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 |
| 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 |
| 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.