FDA Medical Device Recalls (openFDA)
Stryker Spine: Radius Capspin is a non-sterile instrument for use with other devices in spinal surgery.
- Recall number
- Z-1378-2008
- Recalling firm
- Stryker Spine
- Product
- Radius Capspin is a non-sterile instrument for use with other devices in spinal surgery.
- Status
- Terminated
- Initiated
- 2008-02-19
- Posted
- 2008-08-19
- Terminated
- 2008-08-19
- Reason
- The Radius Capsin has separation of the tip from the inserter.
- 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
- 52
- Distribution
- Product was distributed to a limited population during a product launch for the purposes of gathering feedback on the product.
- Lot, serial or model codes
- 06A277, 06A279, 06D632 Catalog number: 486619210
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- 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