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TOTAL KNEE -Procedure Kit recallZ-2293-2024 · American Contract Systems Inc · initiated May 15, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from American Contract Systems Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Under Investigation by firm

What the company is doing

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 [email protected].

Recall details

Recall number
Z-2293-2024
Status
Open, Classified
Initiated by the company
May 15, 2024
Posted by the FDA
Jul 5, 2024
Recalling firm
American Contract Systems Inc
Quantity
50 units
Product code
OJH
Distribution
US Nationwide distribution.

Product description

TOTAL KNEE -Procedure Kit Catalog Number: QPTK95A

Code information (models, lots, serial numbers)

UDI-DI: 00191072201225 LOT#"s: 968241 922241

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 94765).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page