Recall Z-2302-2024 ยท OJH Orthopedic Tray
American Contract Systems Inc
TOTAL KNEE-Procedure Kit Catalog Number: SMTK21C
| Date | Jul 5, 2024 (initiated May 15, 2024) |
| Status | Open, Classified |
| 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. |
| Root cause | Under Investigation by firm |
| Action | American Contract Systems issued Urgent Voluntary Recall Letter (FA-2024-018) via email on 5/15/24 to Distributors. Distributors to notify end-users. Letter states reason for recall, health risk and action to take: Immediately discontinue use of the cast padding component (DISCARD ITEM 4927009046-CAST PADDING, 6" Cotton Blend Rayon) included in each kit/tray identified in ATTACHMENT 1. Please review your inventory, and segregate and quarantine all affected Trays. If any of the affected trays identified above were further distributed, please ensure all end-users are appropriately notified and |
| Quantity | 85 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.