Home › Device types › OQI
Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
FDA product code OQI · Class 2 · Orthopedic
0
Registered devices
179
Adverse events
4
Recalls
5
510(k) clearances
Devices with this code
InSitu Hip System — NEXTSTEP ARTHROPEDIX, LLCUSTAR II Knee System — UNITED ORTHOPEDIC CORP.Kyocera Medical Technologies, Inc. — KYOCERA MEDICAL TECHNOLOGIES, INC.G7 Acetabular Liner — Biomet Orthopedics, LLCKyocera Medical Technologies, Inc. — KYOCERA MEDICAL TECHNOLOGIES, INC.G7® — Biomet Orthopedics, LLCiNSitu™ Hip System — NEXTSTEP ARTHROPEDIX, LLCU-Motion II — UNITED ORTHOPEDIC CORP.G7 — Biomet Orthopedics, LLCUnited Hip System, U-Motion II HA Cup, Multi-Hole — UNITED ORTHOPEDIC CORP.Alteon — Exactech, Inc.G7 PROVISIONAL HIGH WALL LINER — Biomet Orthopedics, LLCG7 Acetabular Liner — Biomet Orthopedics, LLCiNSitu Hip System — NEXTSTEP ARTHROPEDIX, LLCInSitu Hip System — NEXTSTEP ARTHROPEDIX, LLCArcos® One-piece Revision System — Biomet Orthopedics, LLCNovation — Exactech, Inc.ECHO BI-METRIC MICROPLASTY HIP SYSTEM — Biomet Orthopedics, LLCiNSitu™ Hip System — NEXTSTEP ARTHROPEDIX, LLCKyocera Medical Technologies, Inc. — KYOCERA MEDICAL TECHNOLOGIES, INC.G7 Acetabular Liner — Biomet Orthopedics, LLCG7® Vivacit-E® — Zimmer, Inc.G7® Vivacit-E® — Zimmer, Inc.G7® Longevity® — Zimmer, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-12-31 | Exactech, Inc. | Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer. |
| 2024-12-31 | Exactech, Inc. | Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer. |
| 2023-11-21 | Exactech, Inc. | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. |
| 2022-08-25 | Zimmer, Inc. | The outer sterile package cavity has a corner wall thickness that is below the specification. The thin corner wall could potentially crack during transit. Poten |
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