Recall Z-1615-2009 ยท LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Zimmer Inc.
Zimmer femoral stem, revision taper, 15 mm diameter, 185 mm stem length, w/compression nut, sterile, Zimmer, Warsaw, IN; Model Number: 9982-15-18. Cement-less total hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques. Devices placed in femoral canal. A variety of stem and body components are provided to achieve fixation and restore
| Date | Jul 6, 2009 (initiated May 15, 2009) |
| Status | Terminated |
| Reason | The threads on the screw are incomplete/non-functional. |
| Root cause | Process control |
| Action | Zimmer, Inc. began Consignee notification of the affected device via telephone on May 15, 2009. A certified "Urgent: Device Recall" notification dated May 21, 2009 was sent to all consignees instructing them of the affected device, to stop use of and return it with a Return Certification form. The Return Verification form should also be faxed to Zimmer, Inc. at 1-574-372-4265. For shipping assistance, questions or other concerns, contact Zimmer, Inc. at 1-800-613-6131. |
| Quantity | 10 |
| Distribution | Worldwide Distribution -- US states of IA, NE and CA and countries of Canada, Switzerland, United Kingdom, Hungary, Netherlands and Slovakia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K992667 | ZMR HIP SYSTEM-REVISION TAPER Zimmer, Inc., Oct 27, 1999 |