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
This recall has been terminated (originally issued September 21, 2007).
- Company
- Stryker Spine
- Recall Initiated
- July 10, 2007
- Posted
- September 21, 2007
- Terminated
- December 11, 2007
- Recall Number
- Z-1239-2007
- Quantity
- 1,300 in US, 123 in Italy
- Firm Location
- Allendale, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
Product dissembled in the tray or prior to being loaded onto the inserter or tightening on the rod
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
Lot / Code Info
Catalog # 486610000 Lot code: 06C516, 06C358, 06C515, 06C581, 06C447, 06C579, 06C446, 06C467, 06A858 and 06C357
Root Cause
Other
Action Taken
Product recall letters were sent to branches/agencies and hospitals on 7/10/2007 requesting product return.