Radius Rod Persuader is a non-sterile instrument for use with other devices in spinal surgery.
FDA Recall Z-1377-2008 · Posted 2008-08-19
Recalling FirmStryker Spine
Recall StatusTerminated
Product CodeLXH
Date Initiated2008-02-19
Date Terminated2008-08-19
Product Quantity65 units
Reason for Recall
The t-bar of the Radius Rod Persuader devices froze due to a loosening screw causing the device to fail.
Firm 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.
Root Cause
Device Design
Distribution Pattern
Product was distributed to a limited population during a product launch for the purposes of gathering feedback on the product.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.