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Terminated

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

FDA Recall Z-1378-2008 · Posted 2008-08-19

Recalling FirmStryker Spine
Recall StatusTerminated
Product CodeLXH
Date Initiated2008-02-19
Date Terminated2008-08-19
Product Quantity52

Reason for Recall

The Radius Capsin has separation of the tip from the inserter.

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.

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