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U.S. Department of Health and Human Services

Class 2 Device Recall Banner Health

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 Class 2 Device Recall Banner Healthsee related information
Date Initiated by FirmApril 21, 2025
Date PostedJune 06, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1916-2025
Recall Event ID 96837
Product Classification Orthopedic tray - Product Code OJH
ProductLOWER 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 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)
Recalling Firm/
Manufacturer		 American Contract Systems, Inc.
7300 W Detroit St
Chandler AZ 85226-2410
For Additional Information ContactMarlene Jones
602-799-5321
Manufacturer 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 Determined
Cause 2		Finished device change control
ActionOn 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
Quantity in Commerce850 Kits
DistributionUS Nationwide distribution in the state of CO.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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