TOTAL KNEE-Procedure Kit recall
TOTAL KNEE-Procedure Kit Catalog Number: SFTK54B
Why was TOTAL KNEE-Procedure Kit 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 00191072195999 LOT#"s: 680231 997241 969241 947241
- Product
- TOTAL KNEE-Procedure Kit Catalog Number: SFTK54B
- Recalling firm
- American Contract Systems Inc
- Quantity
- 976 units
- Distribution
- US Nationwide distribution.
- Recall date
- July 17, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)