Recall Z-1615-2009
Zimmer Inc. · initiated May 15, 2009
Product
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 joint kinematics.
Codes / lots: Lot Number: 60698102.
Reason for recall
The threads on the screw are incomplete/non-functional.
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-1615-2009
- Initiated
- May 15, 2009
- Posted by FDA
- July 6, 2009
- Terminated
- November 12, 2009
- Product code
- LWJ – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
- Quantity
- 10
- Distribution
- Worldwide Distribution -- US states of IA, NE and CA and countries of Canada, Switzerland, United Kingdom, Hungary, Netherlands and Slovakia.
- Recalling firm
- Zimmer Inc., Warsaw, IN