Citation
132 Degree Neck Angle V40 Hip Stem - Left
7manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
19recalls on this code
Who Else Makes It
Concentrated in Jiangsu (4), Shanghai (2), Zhejiang (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Lincotek (Wuxi) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 7 |
| 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 |
Record
| Listed by | Howmedica Osteonics Corp, United States |
|---|---|
| FDA product code | MAY |
| Device type | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3353 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Manufacturer |
| Record published | 2015-09-24 |
| Record revised | 2025-05-05 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6265-5108 | Size: 8 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Instrument | Howmedica Osteonics Corp | 136 |
| Arcos Modular Revision System | Biomet Orthopedics | 48 |
| Arcos Modular Revision Hip System | Biomet Orthopedics | 40 |
| Ringloc HIP System | Biomet Orthopedics | 36 |
| Restoration | Howmedica Osteonics Corp | 29 |
| Arcos | Biomet Orthopedics | 19 |
| Echo® Bi-Metric® Hip System | Biomet Orthopedics | 18 |
| Trident | Howmedica Osteonics Corp | 12 |
| Arcos® STS™ Modular Revision System | Biomet Orthopedics | 10 |
| Ringloc Ranawat / Burstein HIP System | Biomet Orthopedics | 10 |
| OrthoMedFlex | Orthomedflex LLC | 10 |
| Taperloc Complete Rasp/Provisional | Biomet Orthopedics | 9 |
Showing 12 of 40. All products under Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K123604 | 2013-08-16 |
Recalls
15 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 |
|---|---|---|---|---|---|
| 2016-01-21 | Class II | Under Investigation by firm | During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. | 147,838 units in total | 2017-06-08 |
| 2016-01-21 | Class II | Under Investigation by firm | During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. | 147,838 units in total | 2017-06-08 |
| 2016-01-21 | Class II | Under Investigation by firm | During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. | 147,838 units in total | 2017-06-08 |
| 2016-01-21 | Class II | Under Investigation by firm | During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. | 147,838 units in total | 2017-06-08 |
| 2016-01-21 | Class II | Under Investigation by firm | During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. | 147,838 units in total | 2017-06-08 |
| 2016-01-21 | Class II | Under Investigation by firm | During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. | 147,838 units in total | 2017-06-08 |
| 2016-01-21 | Class II | Under Investigation by firm | During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. | 147,838 units in total | 2017-06-08 |
| 2016-01-21 | Class II | Under Investigation by firm | During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. | 147,838 units in total | 2017-06-08 |
| 2016-01-21 | Class II | Under Investigation by firm | During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. | 147,838 units in total | 2017-06-08 |
| 2016-01-21 | Class II | Under Investigation by firm | During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. | 147,838 units in total | 2017-06-08 |
| 2016-01-21 | Class II | Under Investigation by firm | During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. | 147,838 units in total | 2017-06-08 |
| 2016-01-21 | Class II | Under Investigation by firm | During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. | 147,838 units in total | 2017-06-08 |
| 2016-01-21 | Class II | Under Investigation by firm | During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. | 147,838 units in total | 2017-06-08 |
| 2016-01-21 | Class II | Under Investigation by firm | During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. | 147,838 units in total | 2017-06-08 |
| 2016-01-21 | Class II | Under Investigation by firm | During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. | 147,838 units in total | 2017-06-08 |
| 2005-08-24 | Not classified | Other | The V40 femoral head may not properly engage on the referenced V40 cobal chrome femoral hip stems. | 8487 units | 2006-04-05 |
| 2005-08-24 | Not classified | Other | The V40 femoral head may not properly engage on the referenced V40 cobal chrome femoral hip stems. | 71 units. | 2006-04-05 |
| 2005-08-24 | Not classified | Other | The V40 femoral head may not properly engage on the referenced V40 cobal chrome femoral hip stems. | 207 units | 2006-04-05 |
| 2005-08-24 | Not classified | Other | The V40 femoral head may not properly engage on the referenced V40 cobal chrome femoral hip stems. | 1936 units | 2006-04-05 |
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.