Biolox Delta Modular Head 32mm Extra Long +7.0mm 12/14 Eurocone Taper
Catalogue number 104.3215, listed by Corin Limited, United Kingdom, under Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate. 14 manufacturers in China are registered for this product code.
14manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
14recalls on this code
Who Else Makes It
Concentrated in Jiangsu (8), Shanghai (2), Zhejiang (2). 8 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 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Xian Airfoil Technology Co., Ltd. | Xian | Shaanxi | Contract manufacturer | 8 |
| Lincotek (Wuxi) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 7 |
| b-ONE Medical (Beijing) Co., Ltd. | Beijing | Beijing | 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 |
Showing 12 of 14. All 14 manufacturers in China registered for Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Record
| Listed by | Corin Limited, United Kingdom |
|---|---|
| FDA product code | MEH |
| Device type | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3353 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K130343 |
| Record published | 2016-08-17 |
| Record revised | 2020-09-09 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 104.3215 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Alteon | Exactech, Inc. | 326 |
| Novation | Exactech, Inc. | 317 |
| Pinnacle | Depuy Orthopaedics, Inc. | 305 |
| SP-CL Hip Stem | Waldemar Link GmbH & Co. KG | 219 |
| Emperion | Smith & Nephew, Inc. | 201 |
| MobileLink Acetabular Cup System | Waldemar Link GmbH & Co. KG | 154 |
| Instrument | Howmedica Osteonics Corp | 145 |
| Restoration | Howmedica Osteonics Corp | 144 |
| Mfinity Femoral System | Medacta International SA | 138 |
| Echelon | Smith & Nephew, Inc. | 134 |
| Trinity Acetabular Hip System | Corin Limited | 128 |
| Redapt | Smith & Nephew, Inc. | 127 |
Showing 12 of 805. All products under Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K261576 | 2026-08-10 |
Recalls Naming This Product
2 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 |
|---|---|---|---|---|---|---|---|
| Corin Limited | 510(k) number | 2021-01-25 | Class II | Labeling mix-ups | The size indicated on the labeling on the outer packaging, on the inner packaging, and on the patient stickers inside the packaging is incorrect: the Trinity Biolox Delta Ceramix Head 32XL is labeled as 36XL and vice-versa. | 23 units | 2022-11-23 |
| Corin Limited | 510(k) number | 2021-01-25 | Class II | Labeling mix-ups | The size indicated on the labeling on the outer packaging, on the inner packaging, and on the patient stickers inside the packaging is incorrect: the Trinity Biolox Delta Ceramix Head 32XL is labeled as 36XL and vice-versa. | 23 units | 2022-11-23 |
Recalls
12 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 |
|---|---|---|---|---|---|
| 2021-07-28 | Class II | Storage | The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices. | 5 units | 2024-06-12 |
| 2021-07-28 | Class II | Storage | The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices. | 2 | 2024-06-12 |
| 2021-07-28 | Class II | Storage | The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices. | 2 units | 2024-06-12 |
| 2021-07-28 | Class II | Storage | The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices. | 4 | 2024-06-12 |
| 2021-07-28 | Class II | Storage | The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices. | 5 | 2024-06-12 |
| 2021-07-28 | Class II | Storage | The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices. | 2 units | 2024-06-12 |
| 2021-07-28 | Class II | Storage | The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices. | 1 unit | 2024-06-12 |
| 2021-07-28 | Class II | Storage | The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices. | 6 units | 2024-06-12 |
| 2021-07-28 | Class II | Storage | The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices. | 1 unit | 2024-06-12 |
| 2021-07-28 | Class II | Storage | The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices. | 2 units | 2024-06-12 |
| 2021-05-06 | Class II | Under Investigation by firm | Units from one batch of TriFit TS size 2 stem were found to be labeled as a TriFit CF size 7 stem. And vice versa. | 1 unit | 2023-07-05 |
| 2021-05-06 | Class II | Under Investigation by firm | Units from one batch of TriFit TS size 2 stem were found to be labeled as a TriFit CF size 7 stem. And vice versa. | 4 units | 2023-07-05 |
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.