FDA Medical Device Recalls (openFDA)
American Contract Systems, Inc.: Total Knee Pack, REF CETJ130, medical convenience kits
- Recall number
- Z-1973-2023
- Recalling firm
- American Contract Systems, Inc.
- Product
- Total Knee Pack, REF CETJ130, medical convenience kits
- Status
- Open, Classified
- Initiated
- 2023-04-17
- Posted
- 2023-06-15
- Terminated
- not on file
- Reason
- Incorrect expiration date on product.
- 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 PIQ@owens-minor.com. If you have any questions, contact Regulatory Affairs Manager, Global Products at 470-280-4277 or email: GM-OMRA_RECALLS@owens-minor.com.
- Quantity
- 36 units
- Distribution
- US Distribution to the state of: MA
- Lot, serial or model codes
- UDI/DI: 00191072179593; Lot Number: 967231
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OJH
- Firm FEI
- 3003419114
- Firm city
- Kansas City
- Firm state
- MO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28