FDA recall Z-1391-2022

Aesculap Implant Systems LLC · Class II · device

Product

ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during orthopedic implant surgery.

Reason for recall

Nonfunctional key due to the potential for damage to the key pins cause by force of use during assembly of the tibia locking ring.

Distribution

US Nationwide distribution in the states of AL, AZ, CA, CO, ID, IL, LA, MA, MO, NC, OK, TX, WI.

Key facts

Status
Completed
Initiation date
2019-11-12
Report date
2022-07-27
Voluntary/Mandated
Voluntary: Firm initiated
Location
Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1391-2022