Class 2 Device Recall TENET Wrist Stabilization Kit

• Date Initiated by Firm: November 23, 2007
• Date Posted: February 26, 2008
• Recall Status: Terminated on May 01, 2009
• Recall Number: Z-0578-2008
• Recall Event ID: 46158
• Product Classification: surgical wrist stabilizer - Product Code JEB
• Product: TENET Medical Engineering Wrist Stabilization Kit, Medium; REF (Part) #7692; Sterile; manufactured by TENET Medical Engineering, Calgary, Alberta, Canada T2Z 4M3.
• Code Information: Lot Number: 20060605.
• FEI Number: 3004750931
• 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: 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: 360 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.