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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker T7 Locking Screw

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  Class 2 Device Recall Stryker T7 Locking Screw see related information
Date Initiated by Firm January 28, 2008
Date Posted March 25, 2008
Recall Status1 Terminated 3 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 2		 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.
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