FDANovember 12, 2019device
ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during orthopedic implant surgery.
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Completed
Brands named
aesculap implant systemsaesculapaesculap implant
UPCs
04046963419639
Recall history
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