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
FDA Recall Z-1297-2008 · Posted 2008-03-25
Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeHRS
Date Initiated2008-01-28
Date Terminated2008-06-04
Product Quantity100 units
Reason for Recall
Screws do not have locking threads
Firm 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.
Root Cause
Process control
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.