Z-1916-2025Class II

LOWER EXTREMITY, Model: NCEX20I; LOWER EXTREMITY, Model: NCEX20J; TOTAL KNEE PACK, Model: NCTK31K; TOTAL KNEE...

Name: Z-1916-2025 LOWER EXTREMITY, Model: NCEX20I; LOWER EXTREMITY, Model: NCEX20J; TOTAL KNEE PACK, Model: NCTK31K; TOTAL KNEE...
Creator: American Contract Systems, Inc.
Published: 2025-04-21
License: https://open.fda.gov/license/

American Contract Systems, Inc. / initiated 2025-04-21 / Open, Classified

FDA source

American Contract Systems, Inc. began a recall of LOWER EXTREMITY, Model: NCEX20I; LOWER EXTREMITY, Model: NCEX20J; TOTAL KNEE PACK, Model: NCTK31K; TOTAL KNEE PACK, Model: NCTK31L All convenience kits contain... on 2025-04-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1916-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-04-21
Posted: 2025-06-06
Recalling firm: American Contract Systems, Inc.
Product: 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
Product code: OJH Orthopedic Tray
Reason for recall: 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: Finished device change control
Action: 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]
Quantity in commerce: 850 Kits
Distribution: US Nationwide distribution in the state of CO.
Product codes and lots: 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)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1916-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1916-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-18	2025-06-06

Product code OJH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)