Recall Z-1261-2009 ยท HSB Rod, Fixation, Intramedullary And Accessories
Zimmer Inc.
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.
| Date | May 18, 2009 (initiated Mar 23, 2009) |
| Status | Terminated |
| Reason | The package is labeled as containing 330 mm length nails, but actually contains 300 mm length nails. |
| Root cause | Other |
| Action | 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. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043270 | SIRUS INTRAMEDULLARY NAIL-FEMORAL AND TIBIAL NAILS, MODELS 02.02631, 02.02651, 02.02652 SERIES Zimmer GmbH, Jan 31, 2005 |