Class 2 Device Recall Stryker T7 Locking Screw

• Date Initiated by Firm: January 28, 2008
• Date Posted: March 25, 2008
• Recall Status: Terminated on June 04, 2008
• Recall Number: Z-1297-2008
• Recall Event ID: 46746
• Product Classification: Bone Fixation Locking Screw - Product Code HRS
• Product: Stryker Orthopaedics, Locking Screw, T7, Catalog Number: 40-27622, Size: 2.7X22MM, Non Sterile,Titanium Alloy; Manufactured and Distributed by: Stryker Leibinger GmbH & Co. KG;Boetzinger Strasse 41; 0-79111 Freiburg, Germany
• Code Information: Lot Numbers: H8W00F0B41; H9H00FB41, and H9R00F0B41
• Recalling Firm/ Manufacturer: Stryker Howmedica Osteonics Corp.; 325 Corporate Dr; Mahwah NJ 07430-2002
• For Additional Information Contact: Larry Ross; 201-831-5921
• Manufacturer Reason for Recall: Screws do not have locking threads
• FDA Determined Cause: Process control
• Action: Recall notification letters (Urgent Product Recall) were sent on January 28, 2008 to all Stryker Branches/Agencies by Federal Express. All product distributed was requested to be located and returned, including from hospitals.
• Quantity in Commerce: 100 units
• Distribution: Nationwide-USA including states of MA, PA, GA, OH, and TX (hospital consignees) and Stryker Branches/Agencies in MA, NJ, PA, MD, VA, NC, GA, TN, KY, OH, MI, LK, OK, TX, and CA.
• 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.