FDA Medical Device Recalls (openFDA)
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
- Recall number
- Z-1239-2007
- Recalling firm
- 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
- Status
- Terminated
- Initiated
- 2007-07-10
- Posted
- 2007-09-21
- Terminated
- 2007-12-11
- 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
- Lot, serial or model codes
- Catalog # 486610000 Lot code: 06C516, 06C358, 06C515, 06C581, 06C447, 06C579, 06C446, 06C467, 06A858 and 06C357
- 510(k) numbers
- ["K062270"]
- PMA numbers
- not on file
- Product code
- NKB
- Firm FEI
- 3004024955
- Firm city
- Allendale
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28