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Completed

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

FDA Recall Z-1391-2022 · Posted None

Recalling FirmAesculap Implant Systems LLC
Recall StatusCompleted
Product CodeLXH
Date Initiated2019-11-12
Product Quantity67

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.

Firm 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.

Root Cause

Device Design

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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