UOC Femoral Driver, Product number PE 93045101, orthopedic manual surgical instrument/accessory for use during surgery to implant femoral components and femoral trial, and to remove femoral trial.
FDA Recall Z-1692-2017 · Posted 2017-03-01
Advertisement
Recalling FirmUnited Orthopedic Corporation
Recall StatusTerminated
Product CodeLXH
Date Initiated2017-02-10
Date Terminated2017-06-28
Product Quantity33 units
Reason for Recall
The locking lever pin component of the femoral driver may become deformed and break, resulting in malfunction during surgery and causing the device to become inoperable.
Firm Action
United Orthopedic Corporation sent an Urgent Field Safety Notice dated January 19, 2017, to all affected consignees via e-mail on February 10. 2017. The Urgent Field Safety Notice instructed consignees to recover any affected units and return them to the manufacturer. A redesigned device will be sent for replacements. Consignees with questions were instructed to call 949-328-3366.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution - US including State of CA and Internationally to Pakistan, Spain, and Taiwan.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement