Recall Z-0368-2012 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
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 BUILD-UP TIVANIUM TI-6AL-4V ALLOY STERILE. Item number: 00-9996-019-35
| Date | Nov 16, 2011 |
| Status | Terminated |
| Reason | Lack of assurance of proper metal fatigue strength due to metal grain structure anomaly. In 2006 a recall was initiated as a result of the grain anomaly; however, these 4 lots had been split off during normal production and had not been included in the 2006 recall. |
| Root cause | Nonconforming Material/Component |
| Action | On 11/16/11, Zimmer sent letters titled "URGENT MEDICAL DEVICE RECALL" to distributors via electronic mail and to risk managers and surgeons via FedEx indicating that the product must be immediately removed from use and quarantined. " Stop using the affected lots and place affected product in quarantine. " Review available product on the shelf " Identify those part/lot combinations listed in the recall communication " Immediately remove any implants found that match part/lot combinations listed in the recall communication and quarantine " Return affected lots and signature of acknowledgement t |
| Quantity | 1 unit (Distributed to Demark) |
| Distribution | Worldwide distribution: USA (NY), AUSTRALIA, SWITZERLAND, and DENMARK |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K994286 | ZMR HIP SYSTEM-POROUS REVISION Zimmer, Inc., Mar 10, 2000 |