UOC Femoral Driver, Product number PE 93045101, orthopedic manual surgical instrument/accessory for use during surgery t
FDA device recall Z-1692-2017 · posted 2017-03-01 · Terminated
Recall details
- Recalling firm
- United Orthopedic Corporation
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- LXH
- Quantity affected
- 33 units
- Distribution
- Worldwide Distribution - US including State of CA and Internationally to Pakistan, Spain, and Taiwan.
- Date initiated
- 2017-02-10
- Date posted
- 2017-03-01
- Date terminated
- 2017-06-28
- Location
- Hsinchu, Taiwan
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