Recall Z-0366-2012 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Zimmer Inc.
Zimmer ZMR Femoral Spout & Cone Bodies and Trabecular Metal Primary Hip Prosthesis Femoral Stem SIZE 16 171 MM STEM LENGTH 12/14 NECK TAPER - STANDARD BODY - STANDARD NECK OFFSET TIVANIUM TI-6AL-4V ALLOY/TANTALUM STERILE. Item number: 00-7864-016-00
| 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 | 2 (1 device is domestic) |
| Distribution | Worldwide distribution: USA (NY), AUSTRALIA, SWITZERLAND, and DENMARK |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051491 | TRABECULAR METAL PRIMARY HIP PROSTHESIS Zimmer, Inc., Jun 30, 2005 |