Zimmer Sirus Intramedullary nail for tibia, cannulated, diameter 12 L, 330 mm, sterile, Zimmer GmbH, Winterthur, Switzer
FDA device recall Z-1261-2009 · posted 2009-05-18 · Terminated
Recall details
- Recalling firm
- Zimmer Inc.
- Reason for recall
- The package is labeled as containing 330 mm length nails, but actually contains 300 mm length nails.
- Action taken
- Distributors were initially notified by phone on March 23, 2009. Distributors and user accounts were notified by an "Urgent: Device Recall" letter dated March 31, 2009. The letter described the affected product, reason for recall, risks to health, other information and actions for customers. Customers were instructed to quarantine recalled product and to return it to the Zimmer Distribution Center. For questions about the recall, contact Zimmer, Inc. at 1-800-613-6131.
- Root cause
- Other
- Status
- Terminated
- Product code
- HSB
- Quantity affected
- 32
- Distribution
- Worldwide Distribution -- US (states of Florida, Missouri, New Jersey, New York, Ohio, Oklahoma and Texas) and countries of Austria, Japan, Korea and Germany.
- Date initiated
- 2009-03-23
- Date posted
- 2009-05-18
- Date terminated
- 2009-10-23
- Location
- Warsaw, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SIRUS INTRAMEDULLARY NAIL-FEMORAL AND TIBIAL NAILS, MODELS 02.02631, 02.02651, 02.02652 SERIES (K043270) | Zimmer GmbH | 2005-01-31 |