FDAFebruary 10, 2017device
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 recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Terminated
Brands named
united orthopedicunited
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDAFirst Aid Only BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 50 Wipes, NDC 0924-7116-03.2026-01-20
- FDAMedi-First Antiseptic Wipes (BZK)(Benzalkonium Chloride 0.13%), 100 wipes per box, Manufactured for Medique Products, Fort Meyers, FL, 33967, NDC 47682-122-33.2026-01-20
- FDADynarex Obstetrical Towelettes Cleanser (Benzalkonium Chloride 0.13%), 100 packets, 5" x 7", Manufactured for Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, USA Made in USA, NDC 67777-244-022026-01-20
- FDAHand Sanitizing Wipes (Benzalkonium Chloride 0.13%), 1000 per case, Acme United Corporation, 2280 Tanner Road, Rocky Mount, NC 27801, NDC 0924-0301-002026-01-20
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