Recall Z-1378-2008
Stryker Spine · initiated February 19, 2008
Product
Radius Capspin is a non-sterile instrument for use with other devices in spinal surgery.
Codes / lots: 06A277, 06A279, 06D632 Catalog number: 486619210
Reason for recall
The Radius Capsin has separation of the tip from the inserter.
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-1378-2008
- Initiated
- February 19, 2008
- Posted by FDA
- August 19, 2008
- Terminated
- August 19, 2008
- Product code
- LXH – Orthopedic Manual Surgical Instrument
- Quantity
- 52
- Distribution
- Product was distributed to a limited population during a product launch for the purposes of gathering feedback on the product.
- Recalling firm
- Stryker Spine, Allendale, NJ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1377-2008 | Radius Rod Persuader is a non-sterile instrument for use with other devices in spinal…The t-bar of the Radius Rod Persuader devices froze due to a loosening screw causing the device to fail. | 02/19/2008Terminated |