Enduro Special KEY Tib.lock.ring F1/10mm recall
ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during orthopedic implant surgery.
Why was Enduro Special KEY Tib.lock.ring F1/10mm recalled?
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 should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI (GTIN): 04046963419639
- Product
- ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during orthopedic implant surgery.
- Recalling firm
- Aesculap Implant Systems LLC
- Quantity
- 67
- Distribution
- US Nationwide distribution in the states of AL, AZ, CA, CO, ID, IL, LA, MA, MO, NC, OK, TX, WI.
- Recall date
- July 27, 2022
- Classification
- Class II
- Status
- Completed
- Agency
- FDA (device)