Class 2 Device Recall Stryker Radius Locking Caps

• Date Initiated by Firm: July 10, 2007
• Date Posted: September 21, 2007
• Recall Status: Terminated on December 11, 2007
• Recall Number: Z-1239-2007
• Recall Event ID: 38406
• 510(K)Number: K062270
• Product Classification: Locking cap (Pedicle screw spinal system) - Product Code NKB
• Product: Stryker Radius Locking Caps, Catalog Number: 486610000, Manufactured by Stryker Spine SAS Z.I. Marticot - 33610 Cestas France.,Distributed by Howmedica Osteonics Corp. 325 Corporate Drive, Mahway, NJ 07430
• Code Information: Catalog # 486610000 Lot code: 06C516, 06C358, 06C515, 06C581, 06C447, 06C579, 06C446, 06C467, 06A858 and 06C357
• Recalling Firm/ Manufacturer: Stryker Spine; 2 Pearl Ct; Allendale NJ 07401-1611
• For Additional Information Contact: Michelle Klein; 201-760-8256
• Manufacturer Reason for Recall: Product dissembled in the tray or prior to being loaded onto the inserter or tightening on the rod
• FDA Determined Cause: Other
• Action: Product recall letters were sent to branches/agencies and hospitals on 7/10/2007 requesting product return.
• Quantity in Commerce: 1,300 in US, 123 in Italy
• Distribution: Worldwide- USA: Distributed to Stryker Branches/Agencies in MA, NY, NC. IN, MI, OK, TX,CO, AZ, WI, KS, CA, OR and hospitals in NC IN, MI, MO. KS, TZ, AZ, CA. OR and WA and Country of Italy
• 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.

• 510(K) Database: 510(K)s with Product Code = NKB