Stryker Radius Locking Caps, Catalog Number: 486610000, Manufactured by Stryker Spine SAS Z.I. Marticot - 33610 Cestas F
FDA device recall Z-1239-2007 · posted 2007-09-21 · Terminated
Recall details
- Recalling firm
- Stryker Spine
- Reason for recall
- Product dissembled in the tray or prior to being loaded onto the inserter or tightening on the rod
- Action taken
- Product recall letters were sent to branches/agencies and hospitals on 7/10/2007 requesting product return.
- Root cause
- Other
- Status
- Terminated
- Product code
- NKB
- Quantity affected
- 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
- Date initiated
- 2007-07-10
- Date posted
- 2007-09-21
- Date terminated
- 2007-12-11
- Location
- Allendale, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RADIUS SPINAL SYSTEM (K062270) | Stryker Spine | 2006-11-22 |