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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer Sirus Intramedullary Nail for Tibia

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  Class 2 Device Recall Zimmer Sirus Intramedullary Nail for Tibia see related information
Date Initiated by Firm March 23, 2009
Date Posted May 18, 2009
Recall Status1 Terminated 3 on October 23, 2009
Recall Number Z-1261-2009
Recall Event ID 51687
510(K)Number K043270  
Product Classification Rod, fixation, intramedullary and accessories - Product Code HSB
Product 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.
Code Information Lot Number 2385866.
Recalling Firm/
Manufacturer		 Zimmer Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact
800-613-6131
Manufacturer Reason
for Recall		 The package is labeled as containing 330 mm length nails, but actually contains 300 mm length nails.
FDA Determined
Cause 2		 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 in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HSB and Original Applicant = ZIMMER GMBH
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