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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/
Zimmer Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact
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
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.