Zimmer femoral stem, revision taper, 15 mm diameter, 185 mm stem length, w/compression nut, sterile, Zimmer, Warsaw, IN;
FDA device recall Z-1615-2009 · posted 2009-07-06 · Terminated
Recall details
- Recalling firm
- Zimmer Inc.
- Reason for recall
- The threads on the screw are incomplete/non-functional.
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- LWJ
- Quantity affected
- 10
- Distribution
- Worldwide Distribution -- US states of IA, NE and CA and countries of Canada, Switzerland, United Kingdom, Hungary, Netherlands and Slovakia.
- Date initiated
- 2009-05-15
- Date posted
- 2009-07-06
- Date terminated
- 2009-11-12
- Location
- Warsaw, IN
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ZMR HIP SYSTEM-REVISION TAPER (K992667) | Zimmer, Inc. | 1999-10-27 |