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.
Reported: April 5, 2017 Initiated: February 10, 2017 #Z-1692-2017
Product Description
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.
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.
Details
- Recalling Firm
- United Orthopedic Corporation
- Units Affected
- 33 units
- Distribution
- Worldwide Distribution - US including State of CA and Internationally to Pakistan, Spain, and Taiwan.
- Location
- Hsinchu
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by United Orthopedic Corporation. Units affected: 33 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 5, 2017. Severity: Moderate. Recall number: Z-1692-2017.
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