TOTAL KNEE - 297835-Procedure Kit Catalog Number: RGTK10K
FDA Recall #Z-2296-2024 — Class II — May 15, 2024
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.
Recalling Firm
American Contract Systems Inc — Tiffin, OH
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
24 units
Distribution
US Nationwide distribution.
Code Information
UDI-DI: 00191072203267 LOT#"s: 665231
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated