—#68209

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

FDA product code: HRS — Plate, Fixation, Bone
Device class: Class 2
Medical specialty: Orthopedic
Affected lot / code info: Lot Numbers: H8W00F0B41; H9H00FB41, and H9R00F0B41

Why it was recalled

Screws do not have locking threads

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Dr, Mahwah, New Jersey 07430-2002

Distribution

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.

Timeline

Recall initiated: 2008-01-28
Posted by FDA: 2008-03-25
Terminated: 2008-06-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #68209. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.