FDA-Device2022-07-27Class II
ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during orthopedic implant surgery.
Aesculap Implant Systems LLC
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.
Sold states
US Nationwide distribution in the states of AL, AZ, CA, CO, ID, IL, LA, MA, MO, NC, OK, TX, WI.
Affected count
67
Manufactured in
3773 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during orthopedic implant surgery.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1391-2022Don't want to check this manually?
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