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MAJOR DIEP, Model Nos recallZ-1334-2025 · American Contract Systems Inc · initiated Feb 6, 2025

Class II Open, Classified All recalls posted in March 2025

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

ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.

FDA root cause category: Process control

What the company is doing

The affected distributor was notified via email on 2/16/25, and an updated letter was provided on 2/18/25. The distributor was instructed to notify their end users. Customers were provided with a list of impacted components which are included in the affected trays. Customers were provided with a labeling template and instructed to add warning labels to affected procedure trays to ensure the affected components are discarded.

Recall details

Recall number
Z-1334-2025
Recall class
Class II
Status
Open, Classified
Initiated by the company
Feb 6, 2025
Posted by the FDA
Mar 14, 2025
Recalling firm
American Contract Systems Inc
Quantity
17 kits
Product code
LRO
Distribution
US Nationwide distribution in the state of OH.

Product description

MAJOR DIEP, Model Nos. CCMJ73G-01 CCMJ73H

Code information (models, lots, serial numbers)

UDI-DI 00191072222824 00191072223890 Lots 879241 70-052915

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 96343).

Sources and updates

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