Recall Z-1239-2007 ยท NKB Thoracolumbosacral Pedicle Screw System
Stryker Spine
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
| Date | Sep 21, 2007 (initiated Jul 10, 2007) |
| Status | Terminated |
| Reason | Product dissembled in the tray or prior to being loaded onto the inserter or tightening on the rod |
| Root cause | Other |
| Action | Product recall letters were sent to branches/agencies and hospitals on 7/10/2007 requesting product return. |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062270 | RADIUS SPINAL SYSTEM Stryker Spine, Nov 22, 2006 |