G7 Type 12 / 14 Provisional Head
2 catalogue numbers from 010002541, listed by Biomet Orthopedics, United States, under Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented. 5 manufacturers in China are registered for this product code.
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 |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| 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 | Biomet Orthopedics, United States |
|---|---|
| FDA product code | OQH |
| Device type | Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3350 |
| 510(k) | K121874 |
| Record published | 2016-10-26 |
| Record revised | 2025-05-30 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 010002541 | 36MM, -4MM NECK LENGTH | In distribution |
| 010002549 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| G7® | Biomet Orthopedics | 61 |
| G7 Acetabular Liner | Biomet Orthopedics | 41 |
| G7® Longevity® | Zimmer, Inc. | 20 |
| Restoris Xlve | Mako Surgical Corp. | 20 |
| Continuum® Trilogy® Allofit® | Zimmer, Inc. | 17 |
| Arcos® One-piece Revision System | Biomet Orthopedics | 16 |
| G7® Vivacit-E® | Zimmer, Inc. | 15 |
| RingLoc Hip System | Biomet Orthopedics | 15 |
| Continuum® Trilogy® Allofit® Vivacit-E® | Zimmer, Inc. | 14 |
| Restoris | Mako Surgical Corp. | 12 |
| G7® Acetabular System | Biomet Orthopedics | 11 |
| Sirius | Biomet Orthopedics | 7 |
Showing 12 of 42. All products under Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented
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 | 2022-08-25 | Class II | Under Investigation by firm | The outer sterile package cavity has a corner wall thickness that is below the specification. The thin corner wall could potentially crack during transit. Potential risks include non-clinically or clinically significant extension of surgery | 56 US | |
| Biomet, Inc. | 510(k) number | 2014-05-07 | Class II | Use error | Guide rod may fracture during impaction of the acetabular shell and be retained in the inserter or the patient and could result in a delay in surgery. | 1047 total | 2015-10-30 |
| Biomet, Inc. | 510(k) number | 2014-05-07 | Class II | Use error | Guide rod may fracture during impaction of the acetabular shell and be retained in the inserter or the patient and could result in a delay in surgery. | 1047 total | 2015-10-30 |
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.