UOC Femoral Driver Recalled Due to Locking Lever Pin Breakage Risk
United Orthopedic Corporation is recalling 33 UOC Femoral Drivers because the locking lever pin may deform and break, causing the device to malfunction during surgery.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a surgical instrument becoming inoperable during a procedure, which poses a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
United Orthopedic Corporation is recalling 33 units of the UOC Femoral Driver, product number PE 93045101. This orthopedic manual surgical instrument is used during surgery to implant femoral components and femoral trials, and to remove femoral trials.
The recall is due to a potential defect where the locking lever pin component of the femoral driver may become deformed and break. This failure can result in malfunction during surgery, causing the device to become inoperable.
The affected units were distributed worldwide, including in the United States (specifically California) and internationally to Pakistan, Spain, and Taiwan. The specific lot numbers involved are T16A178A (17 units), T16A178B (1 unit), T16A178B1 (3 units), and T16A178C (12 units). Healthcare facilities and users should stop using these devices and contact the manufacturer for further instructions.
The recalled product
- Product
- 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.
- Manufacturer
- United Orthopedic Corporation
- Affected units
- 33
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot numbers T16A178A (17 units)
- T16A178B (1 unit)
- T16A178B1 (3 units)
- T16A178C (12 units)
Distribution
Distributed in 1 state:
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