Aesculap Implant Systems LLC: Medical Device Recall in 2022 - (Recall #: Z-1391-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: November 12, 2019

Date Posted: July 27, 2022

Recall Number: Z-1391-2022

Event ID: 90484

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.

Status: Completed

Product Quantity: 67

Code Information:

UDI-DI (GTIN): 04046963419639

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated