Z-1378-2008

Radius Capspin is a non-sterile instrument for use with other devices in spinal surgery

Name: Z-1378-2008 Radius Capspin is a non-sterile instrument for use with other devices in spinal surgery
Creator: Stryker Spine
Published: 2008-02-19
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2008-02-19 / Terminated / root cause: design

FDA source

Stryker Spine began a recall of Radius Capspin is a non-sterile instrument for use with other devices in spinal surgery on 2008-02-19. The reason FDA records is "The Radius Capsin has separation of the tip from the inserter". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1378-2008
Status: Terminated
Initiated: 2008-02-19
Posted: 2008-08-19
Terminated: 2008-08-19
Recalling firm: Howmedica Osteonics Corp
Product: Radius Capspin is a non-sterile instrument for use with other devices in spinal surgery.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: The Radius Capsin has separation of the tip from the inserter.
Root cause tag: design
FDA root cause: Device Design
Action: Recall notification was sent via FedEx on February 19, 2008 to all branches/agencies. All questions are to be directed to Michelle Klein, Regulatory Compliance Specialist - 201-760-8256.
Quantity in commerce: 52
Distribution: Product was distributed to a limited population during a product launch for the purposes of gathering feedback on the product.
Product codes and lots: 06A277, 06A279, 06D632 Catalog number: 486619210

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)