FDA Device

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

Hazard

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

What You Should Do

Remedy

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

Products

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
Brand
Stryker Spine
UPC
Catalog # 486610000 Lot code: 06C516, 06C358, 06C515, 06C581, 06C447, 06C579, 06C446, 06C467, 06A858 and 06C357

Units Affected

1,300 in US, 123 in Italy