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HIP SCOPE, Model Nos recallZ-1333-2025 · American Contract Systems Inc · initiated Feb 6, 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

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-1333-2025
Status
Open, Classified
Initiated by the company
Feb 6, 2025
Posted by the FDA
Mar 14, 2025
Recalling firm
American Contract Systems Inc
Quantity
388 kits
Product code
OJH
Distribution
US Nationwide distribution in the state of OH.

Product description

HIP SCOPE, Model Nos. CCHS21B CCHS21B-01 CCHS21B-02

Code information (models, lots, serial numbers)

UDI-DI 00191072193483 Lots 962241 914241 70-050890 70-051579 70-052206 70-053085

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

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