American Contract Systems Inc 2024-07-17 Health serious FDA
Health · FDA · Recall #FDA-Z-2275-2024
TOTAL KNEE - 302497- Procedure tray Catalog Number: ANTK12AF Recall
Issued July 17, 2024 · American Contract Systems Inc
In July 2024, American Contract Systems Inc recalled the TOTAL KNEE - 302497- Procedure tray Catalog Number: ANTK12AF, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
What you should do
- 1 Stop using TOTAL KNEE - 302497- Procedure tray Catalog Number: ANTK12AF right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact American Contract Systems Inc 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
- American Contract Systems Inc
- Category
- Health
- Recall date
- July 17, 2024
- Units affected
- Not reported
- Sold at
- US Nationwide distribution.
- Recall number
- FDA-Z-2275-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- American Contract Systems Inc has 11 recalls in our database, including 1 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.