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  Class 2 Device Recall ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM see related information
Date Initiated by Firm November 12, 2019
Create Date July 15, 2022
Recall Status1 Completed
Recall Number Z-1391-2022
Recall Event ID 90484
Product Classification Orthopedic manual surgical instrument - Product Code LXH
Product ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during orthopedic implant surgery.
Code Information UDI-DI (GTIN): 04046963419639
Recalling Firm/
Aesculap Implant Systems LLC
3773 Corporate Pkwy
Center Valley PA 18034-8217
For Additional Information Contact Josie McBride
Manufacturer 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.
FDA Determined
Cause 2
Device Design
Action A notification letter was issued November 12, 2019 mailed USPS certified with registered return receipt. The letter identified item number NP462R EnduRo Special Key for Tibia Locking Ring F1 10/12mm as being removed from the market for a new version NP462RM after overall system modification. Users are instructed to 1) Review inventory and check that only the latest version (NP462RM and NP454R) are being used. 2) Contact customer service to return any affected inventory. 3) Complete and return the acknowledgement form. Questions are to be directed to Josie McBride at (610) 984-9290.
Quantity in Commerce 67
Distribution US Nationwide distribution in the states of AL, AZ, CA, CO, ID, IL, LA, MA, MO, NC, OK, TX, WI.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.