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

FDA device recall Z-1916-2025 · posted 2025-06-06 · Open, Classified

Recall details

Recalling firm

American Contract Systems, Inc.

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.

Action taken

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 GM-OMRA_RECALLS@owens-minor.com Report any quality problems or adverse events associated with the products listed in this notification to complaints@owens-minor.com

Root cause

Finished device change control

Status

Open, Classified

Product code

OJH

Quantity affected

850 Kits

Distribution

US Nationwide distribution in the state of CO.

Date initiated

2025-04-21

Date posted

2025-06-06

Location

Chandler, AZ