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U.S. Department of Health and Human Services

Class 2 Device Recall Trabecular Metal Reverse Shoulder System

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 Class 2 Device Recall Trabecular Metal Reverse Shoulder Systemsee related information
Date Initiated by FirmFebruary 01, 2007
Date PostedMarch 29, 2007
Recall Status1 Terminated 3 on May 04, 2007
Recall NumberZ-0675-2007
Recall Event ID 37365
Product Classification shoulder implant instrumentation - Product Code LXH
ProductZimmer Trabecular Metal Reverse Shoulder System Instrumentation Conical Reamer, instrument for shoulder arthroplasty, REF no. 00-4309-021-00.
Code Information Lot 60605829.
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 reamer may lock up on the threads of the reamer body rather than spin freely as intended by design.
FDA Determined
Cause 2		Other
ActionZimmer sales staff was notified by letter dated 2/1/07 to pull any of the product from stock and to provide the name and address of their hospital customer accounts for further notification by Zimmer.
Quantity in Commerce4
DistributionCalifornia, Ohio and Texas.
Total Product Life CycleTPLC 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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