Home › Device types › KWZ
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
FDA product code KWZ · Class 2 · Orthopedic
11,111
Registered devices
5,676
Adverse events
19
Recalls
34
510(k) clearances
Devices with this code
Xerxes Hip Stem — SIGNATURE ORTHOPAEDICS PTY LTDPINNACLE — DEPUY ORTHOPAEDICS, INC.P.C.A. — Howmedica Osteonics Corp.Avenir® — Zimmer GmbHTrident X3 Insert — Howmedica Osteonics Corp.G7 PROVISIONAL 10 DEGREE FACE CHANGING LINER — Biomet Orthopedics, LLCArcos® STS™ Modular Revision System — Biomet Orthopedics, LLCG7® — Biomet Orthopedics, LLCMANZA HA NON-CEMENTED CUP — STINSON ORTHOPEDICS INC.FREEDOM RINGLOC HIP SYSTEM — Biomet Orthopedics, LLCDJO SURGICAL — Encore Medical, L.P.ZMR® — Zimmer, Inc.INSTRUMENT — Howmedica Osteonics Corp.INSTRUMENT — Howmedica Osteonics Corp.INSTRUMENT — Howmedica Osteonics Corp.World 20° Hooded Liner Size 48-S — SIGNATURE ORTHOPAEDICS PTY LTDG7 Acetabular Liner — Biomet Orthopedics, LLCG7® Longevity® — Zimmer, Inc.Continuum® Trilogy® Allofit® — Zimmer, Inc.Avenir® Müller — Zimmer GmbHFitmore® — Zimmer GmbHWorld Cup Size 58mm — SIGNATURE ORTHOPAEDICS PTY LTDNA — Exactech, Inc.Alteon — Exactech, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 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. |
| 2012-08-27 | Zimmer, Inc. | Trilogy Longevity Constrained Liner devices were packaged in incorrect cartons. The product is packaged in the incorrect carton. Product labels and patient lab |
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