Zimmer Sirus Intramedullary nail for tibia, cannulated, diameter 12 L, 330 mm, sterile, Zimmer GmbH, Winterthur, Switzerland; REF 02.02631.233. The device is used in orthopedic trauma surgeries for stabilization of tibial bone fractures.
This recall has been terminated (originally issued May 18, 2009).
- Company
- Zimmer Inc.
- Recall Initiated
- March 23, 2009
- Posted
- May 18, 2009
- Terminated
- October 23, 2009
- Recall Number
- Z-1261-2009
- Quantity
- 32
- Firm Location
- Warsaw, IN
- Official Source
- View on FDA website ↗
Reason for Recall
The package is labeled as containing 330 mm length nails, but actually contains 300 mm length nails.
Distribution
Worldwide Distribution -- US (states of Florida, Missouri, New Jersey, New York, Ohio, Oklahoma and Texas) and countries of Austria, Japan, Korea and Germany.
Lot / Code Info
Lot Number 2385866.
Root Cause
Other
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.