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U.S. Department of Health and Human Services

Class 2 Device Recall TENET Wrist Stabilization Kit

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  Class 2 Device Recall TENET Wrist Stabilization Kit see related information
Date Initiated by Firm November 23, 2007
Date Posted February 26, 2008
Recall Status1 Terminated 3 on May 01, 2009
Recall Number Z-0577-2008
Recall Event ID 46158
Product Classification surgical wrist stabilizer - Product Code JEB
Product TENET Medical Engineering Wrist Stabilization Kit, Small; REF (Part) #7691; Sterile; manufactured by TENET Medical Engineering, Calgary, Alberta, Canada T2Z 4M3.
Code Information Lot Number: 20060605.
Recalling Firm/
Manufacturer		 Tenet Medical Engineering Inc
11979 40th St Se /#203 Ab
Calgary Canada
Manufacturer Reason
for Recall		 Sterility compromised: Sterility seals on some of the firm's wrist stabilization kit pouches may be compromised.
FDA Determined
Cause 2		 Packaging process control
Action TENET notified US distributor consignee via Urgent Product Recall Notification letter sent FedEx on 11/23/07. Consignee asked to return product and to contact their consignees to also return product.
Quantity in Commerce 300 units.
Distribution Nationwide Distribution.
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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