Z-2296-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- July 17, 2024
- Initiation Date
- May 15, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24 units
Product Description
TOTAL KNEE - 297835-Procedure Kit Catalog Number: RGTK10K
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution.
Code Information
UDI-DI: 00191072203267 LOT#"s: 665231