FDA-Device2017-04-05Class II
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.
United Orthopedic Corporation
Hazard
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.
Sold states
Worldwide Distribution - US including State of CA and Internationally to Pakistan, Spain, and Taiwan.
Affected count
33 units
Manufactured in
No. 57 Park Avenue 2, Science Park, Hsinchu, Taiwan
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1692-2017Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief