ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during orthopedic implant surgery.
Reported: July 27, 2022 Initiated: November 12, 2019 #Z-1391-2022
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.
Details
- Recalling Firm
- Aesculap Implant Systems LLC
- Units Affected
- 67
- Distribution
- US Nationwide distribution in the states of AL, AZ, CA, CO, ID, IL, LA, MA, MO, NC, OK, TX, WI.
- Location
- Center Valley, PA
Frequently Asked Questions
What product was recalled? ▼
ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during orthopedic implant surgery.. Recalled by Aesculap Implant Systems LLC. Units affected: 67.
Why was this product recalled? ▼
Nonfunctional key due to the potential for damage to the key pins cause by force of use during assembly of the tibia locking ring.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 27, 2022. Severity: Moderate. Recall number: Z-1391-2022.
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