—#208243

Product

TOTAL KNEE-Procedure Kit Catalog Number: SMTK21C

FDA product code: OJH — Orthopedic Tray
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: UDI-DI: 00191072203205 LOT#"s: 975241 956241 920241 907241

Why it was 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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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 maintain records of effectiveness. "Add warning labels to all kits/cases impacted: A labeling template is enclosed for printing warning labels which should be affixed to all affected product in inventory. This label should be affixed to each affected kit and case in a prominently visible location to end-users. The location chosen should not cover any other critical product information found on existing labeling. "Customers (end-users): If you received product from a distributor, please contact the distributor or your sales representative with any questions you may have. "Distributors: If any of the affected kits identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness. "Complete the enclosed Response Form and return as soon as possible. "If credit is requested, please send an email to quality@owens-minor.com.

Recalling firm

Firm: American Contract Systems Inc
Address: 85 Shaffer Park Dr, Tiffin, Ohio 44883-9290

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2024-05-15
Posted by FDA: 2024-07-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #208243. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.