510(k) K994286 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
ZMR HIP SYSTEM-POROUS REVISION
| Applicant | Zimmer, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Mar 10, 2000 |
| Received | Dec 20, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K994286
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 1, 2011 | Zimmer Inc. Zimmer ZMR Hip System Instructions for Use, utilized for the following ZMR devices: Porous Stem,Nitrited Porous Revision, Slotted Porous Bowed Stems with and without Compression Nut, Splined Straight Terminated |
LPH | None listed |
| Dec 1, 2011 | Zimmer Inc. ZMR Porous Revision Hip Prosthesis Surgical Technique, utilized for the following ZMR devices: Porous Stem,Nitrited Porous Revision, Slotted Porous Bowed Stems with and without Compression Nut, Spline Terminated |
LPH | None listed |
| Dec 1, 2011 | Zimmer Inc. ZMR Crossover Instrumentation, utilized for the following ZMR devices: Porous Stem,Nitrited Porous Revision, Slotted Porous Bowed Stems with and without Compression Nut, Splined Straight Stem, Taper S Terminated |
LPH | None listed |
| Dec 1, 2011 | Zimmer Inc. ZMR Over the Junction Instruments for Revision, utilized for the following ZMR devices: Porous Stem,Nitrited Porous Revision, Slotted Porous Bowed Stems with and without Compression Nut, Splined Strai Terminated |
LPH | None listed |
| Nov 16, 2011 | Zimmer Inc. Zimmer ZMR Femoral Spout & Cone Bodies and Trabecular Metal Hip Prosthesis Femoral Stems:
FEMORAL BODY REVISION NITRIDED POROUS 12/14 NECK TAPER EXTENDED 46 MM NECK OFFSET SPOUT BODY SIZE E 55 MM BU Terminated |
LPH | None listed |
| Nov 16, 2011 | Zimmer Inc. Zimmer ZMR Femoral Spout & Cone Bodies and Trabecular Metal Hip Prosthesis Femoral Stems:
FEMORAL BODY REVISION NITRIDED POROUS 12/14 NECK TAPER STANDARD 40 MM NECK OFFSET CONE BODY SIZE C 35 MM B Terminated |
LPH | None listed |
| Aug 31, 2006 | Zimmer Inc. Zimmer ZMR Hip System femoral body, revision, nitrided, porous, 12/14 neck taper, extended, 46 mm neck offset, spout body, size D, 35 mm build-up, tivanium TI-6AL-4V alloy, sterile; REF. 9990-20-46 (C Terminated |
LPH | None listed |
| Aug 31, 2006 | Zimmer Inc. Zimmer ZMR Hip System femoral body, revision, nitrided, porous, 12/14 neck taper, extended, 46 mm neck offset, cone body, size C, 55 mm build-up, tivanium TI-6AL-4V alloy, sterile; REF. 9993-19-55 (Ca Terminated |
LPH | None listed |
| Aug 31, 2006 | Zimmer Inc. Zimmer ZMR Hip System femoral body, revision, nitrided, porous, 12/14 neck taper, standard, 40 mm neck offset, cone body, size C, 35 mm build-up, tivanium TI-6AL-4V alloy, sterile; REF. 9996-19-35 (Ca Terminated |
LPH | None listed |
| Aug 31, 2006 | Zimmer Inc. Zimmer ZMR Hip System femoral body, revision, nitrided, porous, 12/14 neck taper, standard, 40 mm neck offset, cone body, size C, 45 mm build-up, tivanium TI-6AL-4V alloy, sterile; REF. 9996-19-45 (Ca Terminated |
LPH | None listed |
| Aug 31, 2006 | Zimmer Inc. Zimmer ZMR Hip System femoral body, revision, nitrided, porous, 12/14 neck taper, standard, 40 mm neck offset, cone body, size F, 35 mm build-up, tivanium TI-6AL-4V alloy, sterile; REF. 9996-23-35 (Ca Terminated |
LPH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.