CUSTOM KNEE - 206061-Procedure Kit Catalog Number: UDKN68AG
Reported: July 17, 2024 Initiated: May 15, 2024 #Z-2308-2024
Product Description
CUSTOM KNEE - 206061-Procedure Kit Catalog Number: UDKN68AG
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.
Details
- Recalling Firm
- American Contract Systems Inc
- Units Affected
- 174 units
- Distribution
- US Nationwide distribution.
- Location
- Tiffin, OH
Frequently Asked Questions
What product was recalled? ▼
CUSTOM KNEE - 206061-Procedure Kit Catalog Number: UDKN68AG. Recalled by American Contract Systems Inc. Units affected: 174 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 17, 2024. Severity: Moderate. Recall number: Z-2308-2024.
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