Aesculap Implant Systems LLC ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during orthopedic implant surgery. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during orthopedic implant surgery.
Brand
Aesculap Implant Systems LLC
Lot Codes / Batch Numbers
UDI-DI (GTIN): 04046963419639
Products Sold
UDI-DI (GTIN): 04046963419639
Aesculap Implant Systems LLC is recalling ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. in due to Nonfunctional key due to the potential for damage to the key pins cause by force of use during assembly of the tibia locking ring.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Nonfunctional key due to the potential for damage to the key pins cause by force of use during assembly of the tibia locking ring.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026