Home › Device types › KWZ
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
FDA product code KWZ · Class 2 · Orthopedic
0
Registered devices
5,719
Adverse events
20
Recalls
34
510(k) clearances
Devices with this code
TAPERLOC COMPLETE RASP/PROVISIONAL — Biomet Orthopedics, LLCArcos Modular Revision Hip System — Biomet Orthopedics, LLCEcho® Press-Fit Hip System — Biomet Orthopedics, LLCArcos® Revision Hip Instrumentation — Biomet Uk LtdModulus Hip System — LIMACORPORATE SPAOSS™ Orthopedic Salvage System — Biomet Orthopedics, LLCTrident — Howmedica Osteonics Corp.INSTRUMENT — Howmedica Osteonics Corp.RINGLOC RX90-2 HIP SYSTEM — Biomet Orthopedics, LLCAvenir® Müller — Zimmer GmbHWagner Cone Prosthesis® — Zimmer GmbHTrident — Howmedica Osteonics Corp.ZMR® — Zimmer, Inc.NA — Zimmer, Inc.G7 Acetabular Liner — Biomet Orthopedics, LLCINSTRUMENT — Howmedica Osteonics Corp.Logical 20° Hooded Liner — SIGNATURE ORTHOPAEDICS PTY LTDINSTRUMENT — Howmedica Osteonics Corp.Trident II — Howmedica Osteonics Corp.OSS™ Orthopedic Salvage System — Biomet Orthopedics, LLCTrident — Howmedica Osteonics Corp.INSTRUMENT — Howmedica Osteonics Corp.INSTRUMENT — Howmedica Osteonics Corp.G7® — Biomet Orthopedics, LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-30 | Howmedica Osteonics Corp. | Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential f |
| 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. |
| 2022-08-11 | Exactech, Inc. | Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear. |
| 2022-08-11 | Exactech, Inc. | Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear. |
| 2018-09-21 | Encore Medical, Lp | Complaints regarding loose proximal body bolts or bolts that were found through x-ray as sitting above the proximal body and not properly seated. Patient risks |
| 2015-05-06 | Smith & Nephew, Inc. | The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allow the locking ring to engage into the R3 shell. |
| 2015-05-06 | Smith & Nephew, Inc. | The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allow the locking ring to engage into the R3 shell. |
| 2015-05-06 | Smith & Nephew, Inc. | The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allow the locking ring to engage into the R3 shell. |
| 2015-05-06 | Smith & Nephew, Inc. | The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allow the locking ring to engage into the R3 shell. |
| 2015-05-06 | Smith & Nephew, Inc. | The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allow the locking ring to engage into the R3 shell. |
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