FDAFDA · Food and drugs·Recall number Z-2302-2024
TOTAL KNEE-Procedure Kit Catalog Number: SMTK21C
Published July 17, 2024 · Recall initiated: May 15, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- American Contract Systems Inc
- Distributor
- US Nationwide distribution.
- Lot
- UDI-DI: 00191072203205 LOT#"s: 975241 956241 920241 907241
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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