FDAFDA · Food and drugs·Recall number Z-1391-2022
ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during orthopedic implant surgery.
Published July 27, 2022 · Recall initiated: November 12, 2019
Status when published: Completed — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Nonfunctional key due to the potential for damage to the key pins cause by force of use during assembly of the tibia locking ring.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Aesculap Implant Systems LLC
- Distributor
- US Nationwide distribution in the states of AL, AZ, CA, CO, ID, IL, LA, MA, MO, NC, OK, TX, WI.
- Lot
- UDI-DI (GTIN): 04046963419639
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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