Reported Jul 17, 2024 · Ongoing
MAJOR KNEE - 302497- Procedure tray Catalog Number: ASKN23B
American Contract Systems Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: American Contract Systems Inc · 85 Shaffer Park Dr · Tiffin, OH · 44883-9290
Is this the product you have?
- MAJOR KNEE - 302497-
- Procedure tray Catalog NumberASKN23B
- Lot codes and dates
- UDI-DI00191072216885 LOT#"s: 946241
- Amount recalled
- 26 units
This recall covers 39 products
The agency filed one notice per product. You are reading one of them; the other 38 are below.
26 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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