Total Knee Pack, REF CETJ130, medical convenience kits recallZ-1973-2023 · American Contract Systems, Inc. · initiated Apr 17, 2023
Open, Classified
Is my device affected?
- 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.
- 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.
- 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
Incorrect expiration date on product.
FDA root cause category: Labeling design
What the company is doing
Owens & Minor sent an "URGENT Product Field Correction" notice on 04/17/2023 to its sole consignee by email. The notice explained the issue and requested the following actions be taken: Identify and segregate and quarantine the affected kits in inventory. Notify all end users of this action and add labels containing correct expiration to kits. The affected product is to be relabeled using the labeling template provided. Report any quality problems or adverse events associated with the products listed in this notification to [email protected]. If you have any questions, contact Regulatory Affairs Manager, Global Products at 470-280-4277 or email: [email protected].
Recall details
- Recall number
- Z-1973-2023
- Status
- Open, Classified
- Initiated by the company
- Apr 17, 2023
- Posted by the FDA
- Jun 15, 2023
- Recalling firm
- American Contract Systems, Inc.
- Quantity
- 36 units
- Product code
- OJH
- Distribution
- US Distribution to the state of: MA
Product description
Total Knee Pack, REF CETJ130, medical convenience kits
Code information (models, lots, serial numbers)
UDI/DI: 00191072179593; Lot Number: 967231
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ACS CETJ13OAmerican Contract Systems, Inc. · Orthopedic tray1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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