Z-1239-2007

Stryker Radius Locking Caps, Catalog Number: 486610000, Manufactured by Stryker Spine SAS Z.I. Marticot...

Name: Z-1239-2007 Stryker Radius Locking Caps, Catalog Number: 486610000, Manufactured by Stryker Spine SAS Z.I. Marticot...
Creator: Stryker Spine
Published: 2007-07-10
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2007-07-10 / Terminated / root cause: packaging

FDA source

Stryker Spine began a recall of Stryker Radius Locking Caps, Catalog Number: 486610000, Manufactured by Stryker Spine SAS Z.I. Marticot - 33610 Cestas France.,Distributed by Howmedica... on 2007-07-10. The reason FDA records is "Product dissembled in the tray or prior to being loaded onto the inserter or tightening on the rod". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1239-2007
Status: Terminated
Initiated: 2007-07-10
Posted: 2007-09-21
Terminated: 2007-12-11
Recalling firm: Howmedica Osteonics Corp
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
Product code: NKB Thoracolumbosacral Pedicle Screw System
Reason for recall: Product dissembled in the tray or prior to being loaded onto the inserter or tightening on the rod
Root cause tag: packaging
FDA root cause: Other
Action: Product recall letters were sent to branches/agencies and hospitals on 7/10/2007 requesting product return.
Quantity in commerce: 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
Product codes and lots: Catalog # 486610000 Lot code: 06C516, 06C358, 06C515, 06C581, 06C447, 06C579, 06C446, 06C467, 06A858 and 06C357

Product code NKB

K062270Class IIRadius Spinal SystemStryker Spine / cleared 2006-11-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)