Recall Z-1391-2022— Aesculap Implant Systems LLC
Class II · Completed
Class II FDA medical device recall by Aesculap Implant Systems LLC, initiated 2019-11-12. FDA's recall record names no specific 510(k) clearance for this event. 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: Nonfunctional key due to the potential for damage to the key pins cause by force of use during assembly of the tibia locking ring..
- Recalling firm
- Aesculap Implant Systems LLC
- Classification
- Class II
- Status
- Completed
- Initiated
- 2019-11-12
- Firm location
- Center Valley, PA, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.