Aesculap Implant Systems LLC 2022-07-27 Health serious FDA
Health · FDA · Recall #FDA-Z-1391-2022
ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee… Recall
Issued July 27, 2022 · Aesculap Implant Systems LLC
In July 2022, Aesculap Implant Systems LLC recalled the ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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 you should do
- 1 Stop using ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Aesculap Implant Systems LLC to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Aesculap Implant Systems LLC
- Category
- Health
- Recall date
- July 27, 2022
- Units affected
- Not reported
- Sold at
- US Nationwide distribution in the states of AL, AZ, CA, CO, ID, IL, LA, MA, MO, NC, OK, TX, WI.
- Recall number
- FDA-Z-1391-2022
- Made in
- United States
- Issuing agency
- FDA
In context
- Aesculap Implant Systems LLC has 4 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.