Tandem
Tandem Unipolar 12/14 Taper Sleeve + 12
5manufacturers in China registered for this device type
24catalogue numbers in this listing
1510(k) clearance
1recall
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (2), 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 |
|---|---|---|---|---|
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Smith & Nephew, Inc., United States |
|---|---|
| FDA product code | LZY |
| Device type | Prosthesis, Hip, Hemi-, Femoral, Metal Ball |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3360 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K896580 |
| Record published | 2015-08-30 |
| Record revised | 2025-12-22 (version 8) |
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, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 71326603 | In distribution | |
| 126651 | In distribution | |
| 71326604 | In distribution | |
| 71326600 | In distribution | |
| 126650 | In distribution | |
| 126659 | In distribution | |
| 126643 | In distribution | |
| 126645 | In distribution | |
| 71326608 | In distribution | |
| 126649 | In distribution | |
| 126644 | In distribution | |
| 126647 | In distribution | |
| 126653 | In distribution | |
| 126641 | In distribution | |
| 126655 | In distribution | |
| 126654 | In distribution | |
| 126652 | In distribution | |
| 71326612 | In distribution | |
| 126657 | In distribution | |
| 126646 | In distribution | |
| 126642 | In distribution | |
| 126661 | In distribution | |
| 126648 | In distribution | |
| 126640 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Endohead | Medacta International SA | 51 |
| Quadra P femoral stems | Medacta International SA | 27 |
| Prosthesis, Hip, Hemi-, Femoral, Metal Ball | Depuy Orthopaedics, Inc. | 21 |
| B-P Total HIP System | Endotec, Inc. | 20 |
| Balance Microplasty HIP System | Biomet Orthopedics | 6 |
| Prosthesis, Hip, Hemi-, Femoral, Metal Ball | Smith & Nephew, Inc. | 4 |
| Sirius® Hip System | Biomet Orthopedics | 3 |
| Taperloc Microplasty HIP System | Biomet Orthopedics | 3 |
| Sirius | Biomet Orthopedics | 3 |
| Balance HIP System | Biomet Orthopedics | 3 |
| Cureguard | Jiangsu Cureguard Glove Co., Ltd. | 1 |
| Masterloc Femoral Stems | Medacta International SA | 1 |
Showing 12 of 13. All products under Prosthesis, Hip, Hemi-, Femoral, Metal Ball
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K231448 | 2023-07-19 |
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 |
|---|---|---|---|---|---|
| 2009-01-12 | Not classified | Process control | 46 mm Femoral head was mismarked and packaged as being 45 mm | 10 units | 2011-03-25 |
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.