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Aesculap Implant Systems LLC recalls ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during
Recalled July 27, 2022 · FDA recall Z-1391-2022 · Aesculap Implant Systems
Hazard
Nonfunctional key due to the potential for damage to the key pins cause by force of use during assembly of the tibia locking ring. · FDA Class II
Units
67
Sold at
US Nationwide distribution in the states of AL, AZ, CA, CO, ID, IL, LA, MA, MO, NC, OK, TX, WI.
Description
Nonfunctional key due to the potential for damage to the key pins cause by force of use during assembly of the tibia locking ring.
Product
ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during orthopedic implant surgery.
Manufacturer(s)
Aesculap Implant Systems LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →