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.
Recall
- Recall Number
- Z-1615-2009
- Event Number
- 52128
- Firm
- Zimmer Inc.
- FEI Number
- 1000220733
- Product Code
- LWJ
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- May 15, 2009
- Posted
- July 6, 2009
- Terminated
- November 12, 2009
- Address
- 345 E Main St, Warsaw, IN, 46580-2746
Description
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.
The threads on the screw are incomplete/non-functional.
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.
Worldwide Distribution -- US states of IA, NE and CA and countries of Canada, Switzerland, United Kingdom, Hungary, Netherlands and Slovakia.
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