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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer Trabecular

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  Class 2 Device Recall Zimmer Trabecular see related information
Date Initiated by Firm October 19, 2006
Date Posted November 22, 2006
Recall Status1 Terminated 3 on December 05, 2007
Recall Number Z-0210-2007
Recall Event ID 36657
Product Classification shoulder prosthesis instrumentation - Product Code HWT
Product Zimmer Trabecular metal shoulder instrumentation proximal provisional humeral stem, 48 degrees, 9/10 mm diameter, nonsterile; REF 4309-18-10, Catalog no. 00-4309-018-10.
Code Information Lots 60457716 and 60492624.
Recalling Firm/
Manufacturer		 Zimmer Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact
800-846-4637
Manufacturer Reason
for Recall		 The instrument may fracture at the threaded end during intramedullary trialing and leave the distal pilot trial in the humeral canal.
FDA Determined
Cause 2		 Other
Action The firm''s sales force was notified via recall letter dated 10/19/06 to secure product from customer accounts and to return it to Zimmer.
Quantity in Commerce 50
Distribution Nationwide and Australia.
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.
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