Bigliani/Flatow®
86 catalogue numbers from 4303-52-18, listed by Zimmer, Inc., United States, under Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented. 8 manufacturers in China are registered for this product code.
8manufacturers in China registered for this device type
86catalogue numbers in this listing
1510(k) clearance
3recalls on this code
Who Else Makes It
Concentrated in Shanghai (3), Jiangsu (3), Zhejiang (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Zimmer, Inc., United States |
|---|---|
| FDA product code | HSD |
| Device type | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3690 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K103404 |
| Record published | 2016-07-14 |
| Record revised | 2023-05-03 (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, serial number |
| Sizes | Length 178 to 298 mm |
| Distribution end date | 2017-03-24 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 4303-52-18 | 18 mm Head Height, 52 mm Spherical Head Diameter | In distribution | |
| 00-4307-066-40 | 40 mm Cannulated Straight | In distribution | |
| 4301-95-50 | In distribution | ||
| 4300-18-13 | 18 mm Stem Diameter, 130 mm Stem Length | In distribution | |
| 4302-40-15 | 15 mm Head Height, 40 mm Spherical Head Diameter | In distribution | |
| 4300-82 | 52 mm Diameter Articular Surface | In distribution | |
| 4300-80 | 40 mm Diameter Articular Surface | In distribution | |
| 4301-02-01 | In distribution | ||
| 4301-26-40 | 40 mm Glenoid Slot Guide | In distribution | |
| 4301-07-01 | Length 178 mm | In distribution | |
| 4301-46-30 | 30 mm Head Height, 46 mm Spherical Head Diameter | In distribution | |
| SSI004723 | 40 mm | In distribution | |
| 4301-77-40 | 40 mm Diameter | In distribution | |
| 4300-40-18 | 18 mm Head Height, 40 mm Spherical Head Diameter | In distribution | |
| 4303-75-01 | 3 | In distribution | |
| 4301-15 | 15 mm Diameter | In distribution | |
| 00-4302-056-30 | 30 mm Head Height, 56 mm Spherical Head Diameter | In distribution | |
| 4300-15-13 | 15 mm Stem Diameter, 130 mm Stem Length | In distribution | |
| 4300-85 | 40 mm Diameter Articular Surface | In distribution | |
| 4303-46-23 | 23 mm Head Height, 46 mm Spherical Head Diameter | In distribution | |
| 4300-40-46 | 46 mm Diameter Articular Surface | In distribution | |
| 4303-46-30 | 30 mm Head Height, 46 mm Spherical Head Diameter | In distribution | |
| 4300-12-13 | 12 mm Stem Diameter, 130 mm Stem Length | In distribution | |
| 4301-46-15 | 15 mm Head Height, 46 mm Spherical Head Diameter | In distribution | |
| 4301-36-40 | 40 mm Peg Sizer/Pressurizer | In distribution | |
| 4302-52-23 | 23 mm Head Height, 52 mm Spherical Head Diameter | In distribution | |
| 4300-14-17 | 14 mm Stem Diameter, 170 mm Stem Length | In distribution | |
| 4303-40-21 | 21 mm Head Height, 40 mm Spherical Head Diameter | In distribution | |
| 4301-08-01 | 8 mm Diameter | In distribution | |
| 4301-29-40 | 40 mm Glenoid Reamer | In distribution | |
| 4303-54 | In distribution | ||
| SSI005084 | In distribution | ||
| 4300-52-56 | 56 mm Diameter Articular Surface | In distribution | |
| 4301-02-02 | In distribution | ||
| 4300-46-30 | 30 mm Head Height, 46 mm Spherical Head Diameter | In distribution | |
| 4302-46-24 | 24 mm Head Height, 46 mm Spherical Head Diameter | In distribution | |
| 4300-13-13 | 13 mm Stem Diameter, 130 mm Stem Length | In distribution | |
| 4301-06 | Length 298 mm | In distribution | |
| 4302-46-18 | 18 mm Head Height, 46 mm Spherical Head Diameter | In distribution | |
| 4300-52-24 | 24 mm Head Height, 52 mm Spherical Head Diameter | In distribution | |
| 4301-74-17 | 17 mm Diameter | In distribution | |
| 4301-01-04 | In distribution | ||
| 4301-74-14 | 14 mm Diameter | In distribution | |
| 4301-01-09 | In distribution | ||
| 4301-63 | 40 mm Diameter | In distribution | |
| 4301-13 | Length 298 mm | In distribution | |
| 4301-56-42 | 42 mm Head Height, 56 mm Spherical Head Diameter | In distribution | |
| 4300-09-13 | 9 mm Stem Diameter, 130 mm Stem Length | In distribution | |
| 4303-46-19 | 19 mm Head Height, 46 mm Spherical Head Diameter | In distribution | |
| 4302-46-52 | 52 mm Diameter Articular Surface | In distribution | |
| 4302-46-30 | 30 mm Head Height, 46 mm Spherical Head Diameter | In distribution | |
| 4301-11 | Length 298 mm | In distribution | |
| 4300-10-17 | 10 mm Stem Diameter, 170 mm Stem Length | In distribution | |
| 4302-40-18 | 18 mm Head Height, 40 mm Spherical Head Diameter | In distribution | |
| 4300-82 | 52 mm Diameter Articular Surface | In distribution | |
| 4303-52-23 | 23 mm Head Height, 52 mm Spherical Head Diameter | In distribution | |
| 4303-46-40 | 40 mm Diameter | In distribution | |
| 4301-74-12 | 12 mm Diameter | In distribution | |
| 4301-37 | In distribution | ||
| 4301-34-01 | 2 | In distribution | |
| 4302-46-40 | 40 mm Diameter Articular Surface | In distribution | |
| 4301-41 | 6 mm Stem Diameter, 130 mm Stem Length | In distribution | |
| 4302-40-24 | 24 mm Head Height, 40 mm Spherical Head Diameter | In distribution | |
| 4300-46-27 | 27 mm Head Height, 46 mm Spherical Head Diameter | In distribution | |
| SSI004725 | 52 mm | In distribution | |
| 00-4302-056-18 | 18 mm Head Height, 56 mm Spherical Head Diameter | In distribution | |
| 4301-46-33 | 33 mm Head Height, 46 mm Spherical Head Diameter | In distribution | |
| 4300-40-24 | 24 mm Head Height, 40 mm Spherical Head Diameter | In distribution | |
| 4301-52-46 | 46 mm Diameter | In distribution | |
| 4300-40-15 | 15 mm Head Height, 40 mm Spherical Head Diameter | In distribution | |
| 4301-52-18 | 18 mm Head Height, 52 mm Spherical Head Diameter | In distribution | |
| 4300-07-13 | 7 mm Stem Diameter, 130 mm Stem Length | In distribution | |
| 4301-47 | 10 mm Stem Diameter, 130 mm Stem Length | In distribution | |
| 4302-52-46 | 46 mm Diameter Articular Surface | In distribution | |
| 00-4302-056-23 | 23 mm Head Height, 56 mm Spherical Head Diameter | In distribution | |
| 4300-81 | 46 mm Diameter Articular Surface | In distribution | |
| 4301-43 | 7 mm Stem Diameter, 130 mm Stem Length | In distribution | |
| 4300-81 | 46 mm Diameter Articular Surface | In distribution | |
| 4301-40-21 | 21 mm Head Height, 40 mm Spherical Head Diameter | In distribution | |
| 4302-40-27 | 27 mm Head Height, 40 mm Spherical Head Diameter | In distribution | |
| 4300-46-52 | 52 mm Diameter Articular Surface | In distribution | |
| 4302-46-40 | 40 mm Diameter Articular Surface | In distribution | |
| 4300-56-30 | 30 mm Head Height, 56 mm Spherical Head Diameter | In distribution | |
| 4301-16 | 16 mm Diameter | In distribution | |
| 4301-79 | Withdrawn | ||
| 4301-73-01 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Equinoxe | Exactech, Inc. | 345 |
| SMR Shoulder | Limacorporate | 182 |
| FX V135 | Fx Shoulder Solutions SAS | 127 |
| Acumed | Acumed LLC | 112 |
| Promos | Smith & Nephew, Inc. | 104 |
| Trabecular Metal® | Zimmer, Inc. | 90 |
| Comprehensive® Shoulder System | Biomet Orthopedics | 85 |
| Arthrex® | Arthrex, Inc. | 75 |
| SMR System | Limacorporate | 72 |
| DJO Surgical | Encore Medical, L.P. | 70 |
| Humeris Shoulder | Fx Solutions | 69 |
| Prima | Limacorporate | 67 |
Showing 12 of 241. All products under Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K161620 | 2016-11-01 |
Recalls Naming This Product
3 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 | 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 | 2013-06-11 | Class II | Packaging process control | The firm is initiating a removal of one lot of the Bigliani/Flatow Humeral Provisional Stem (00-4301-012-17, lot 62283991) as the stems manufactured under the lot are 14mm x 170mm devices incorrectly etched and packaged as 12mm x 170mm devi | 1 | 2014-01-30 |
| Zimmer, Inc. | 510(k) number | 2012-05-12 | Class II | Mixed-up of materials/components | Bigliani/Flatow The Complete Shoulder Solution Trabecular Metal Glenoid Instrument Drill with Stop, 6 mm. Catalog number 47-4301-031-00 was actually packaged and labeled as catalog number 47-4307-031-00, lot 62071190. | 87 units | 2013-09-12 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2009-09-17 | Not classified | Other | Some of the devices may possess a taper which will not mate with the humeral head, as intended. | 12 | 2009-12-22 |
| 2009-09-17 | Not classified | Other | Some of the devices may possess a taper which will not mate with the humeral head, as intended. | 12 | 2009-12-22 |
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.