FDA Device recall Z-2308-2024
CUSTOM KNEE - 206061-Procedure Kit Catalog Number: UDKN68AG
- FDA Device
- Class II
- ongoing
- Published 2024-07-17
On 2024-07-17 the FDA classified a Class II recall of CUSTOM KNEE - 206061-Procedure Kit Catalog Number: UDKN68AG by American Contract Systems, citing 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 10….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2308-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-05-15 |
| Published | 2024-07-17 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | American Contract Systems |
| Distribution | US |
Product
CUSTOM KNEE - 206061-Procedure Kit Catalog Number: UDKN68AG
Reason
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.
Identifiers
| code_info | UDI-DI: 00191072216335 LOT#"s: 955241 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2308-2024%22
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