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.
FDA Recall Z-1261-2009 · Posted 2009-05-18
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Recalling FirmZimmer Inc.
Recall StatusTerminated
Product CodeHSB
Date Initiated2009-03-23
Date Terminated2009-10-23
Product Quantity32
Reason for Recall
The package is labeled as containing 330 mm length nails, but actually contains 300 mm length nails.
Firm 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.
Root Cause
Other
Distribution Pattern
Worldwide Distribution -- US (states of Florida, Missouri, New Jersey, New York, Ohio, Oklahoma and Texas) and countries of Austria, Japan, Korea and Germany.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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