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U.S. Department of Health and Human Services

Class 2 Device Recall Trabecular Metal Shoulder Instrumentation

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  Class 2 Device Recall Trabecular Metal Shoulder Instrumentation see related information
Date Initiated by Firm June 16, 2006
Date Posted July 27, 2006
Recall Status1 Terminated 3 on December 05, 2007
Recall Number Z-1274-06
Recall Event ID 35783
Product Classification shoulder prosthesis instrument - Product Code HWT
Product Zimmer Trabecular Metal Shoulder Instrumentation Distal Pilot, 11 mm diameter, 130 mm length, non-sterile, catalog no. 4309-11-13 (00-4309-011-13).
Code Information All lots.
Recalling Firm/
Manufacturer		 Zimmer Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact
800-846-4637
Manufacturer Reason
for Recall		 During provisional trialing, the instrument may become stuck in the humeral canal and require surgical removal.
FDA Determined
Cause 2		 Other
Action U.S. and international distributors were notified of the recall via letter dated 6/30/2006 to check customer inventories and to return recalled product to the firm. Trial implants were redesigned and reworked to eliminate the problem.
Quantity in Commerce 324 total
Distribution Nationwide and worldwide including Australia, Canada, Germany, Italy and Spain.
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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