Radius Capspin is a non-sterile instrument for use with other devices in spinal surgery.
FDA device recall Z-1378-2008 · posted 2008-08-19 · Terminated
Recall details
- Recalling firm
- Stryker Spine
- Reason for recall
- The Radius Capsin has separation of the tip from the inserter.
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LXH
- Quantity affected
- 52
- Distribution
- Product was distributed to a limited population during a product launch for the purposes of gathering feedback on the product.
- Date initiated
- 2008-02-19
- Date posted
- 2008-08-19
- Date terminated
- 2008-08-19
- Location
- Allendale, NJ
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