Z-1973-2023Class III

Total Knee Pack, REF CETJ130, medical convenience kits

Name: Z-1973-2023 Total Knee Pack, REF CETJ130, medical convenience kits
Creator: American Contract Systems, Inc.
Published: 2023-04-17
License: https://open.fda.gov/license/

American Contract Systems, Inc. / initiated 2023-04-17 / Open, Classified / root cause: labeling and UDI

FDA source

American Contract Systems, Inc. began a recall of Total Knee Pack, REF CETJ130, medical convenience kits on 2023-04-17. FDA classified it as Class III and gives the reason as "Incorrect expiration date on product". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1973-2023
Classification: Class III
Status: Open, Classified
Initiated: 2023-04-17
Posted: 2023-06-15
Recalling firm: American Contract Systems, Inc.
Product: Total Knee Pack, REF CETJ130, medical convenience kits
Product code: OJH Orthopedic Tray
Reason for recall: Incorrect expiration date on product.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: 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].
Quantity in commerce: 36 units
Distribution: US Distribution to the state of: MA
Product codes and lots: UDI/DI: 00191072179593; Lot Number: 967231

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1973-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1973-2023	Class III	Ongoing	Voluntary: Firm initiated	2023-06-21	2023-06-15

Product code OJH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)