Skip to content

LOWER EXTREMITY, Model: NCEX20I recallZ-1916-2025 · American Contract Systems, Inc. · initiated Apr 21, 2025

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

Test results for cast padding component included in procedure trays shows Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals exceeded residual limits, which may lead to a possible loss or lack of functionality that may lead to a delay or prolonged treatment/procedure/therapy.

FDA root cause category: Finished device change control

What the company is doing

On 4/21/2025, correction notices were emailed to the customer who was asked to do the following: 1) Discontinue use of the Cast Padding component. All other components within the kit can be used. 2) Add warning labels to affected kits in Table 2 to ensure the component is discarded. A labeling template is enclosed for printing labels which can be affixed on all affected kits in inventory. This label should be applied to each affected Procedure tray and product case in a prominently visible location to end-users. The location chosen should not cover any other critical product information found on existing product 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 procedure trays identified above were further distributed, please ensure all end-users are appropriately notified of this product correction and maintain records of effectiveness. You are also responsible for the reconciliation of these customers. Please do not have your customers respond directly to ACS. Complete and return the response form via email to [email protected] Report any quality problems or adverse events associated with the products listed in this notification to [email protected]

Recall details

Recall number
Z-1916-2025
Status
Open, Classified
Initiated by the company
Apr 21, 2025
Posted by the FDA
Jun 6, 2025
Recalling firm
American Contract Systems, Inc.
Quantity
850 Kits
Product code
OJH
Distribution
US Nationwide distribution in the state of CO.

Product description

LOWER EXTREMITY, Model: NCEX20I; LOWER EXTREMITY, Model: NCEX20J; TOTAL KNEE PACK, Model: NCTK31K; TOTAL KNEE PACK, Model: NCTK31L All convenience kits contain Specialist Blend Cast Padding, Item: QTX30-322NS

Code information (models, lots, serial numbers)

Model/UDI-DI/Lot(Expiration): NCEX20I/00191072222398/9146304(2025-12-03), 9207685(2026-01-08); NCEX20J/00191072234582/9222096(2026-01-30), 9222096(2026-01-30); NCTK31K/00191072222480/9086225(2025-11-01), 9086225(2025-11-01); NCTK31L/00191072234872/9219596(2026-01-15), 9219596(2026-01-15)

Devices named in this recall

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

Sources and updates

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