Recalling Firm / Manufacturer

Stryker Spine

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

Reason of Recall

Product dissembled in the tray or prior to being loaded onto the inserter or tightening on the rod

Date Recall Initiated

July 10, 2007

Action

Product recall letters were sent to branches/agencies and hospitals on 7/10/2007 requesting product return. Firm Initiated recall is ongoing.

Contact

Al-Faisaliah Medical System
Riyadh
(01) 2119988

Source of Information

U.S. FDA

SFDA Comments

SFDA urges all hospitals that have devices subjected to recall, to contact the company.