Recall Z-1973-2023 ยท OJH Orthopedic Tray
American Contract Systems, Inc.
Total Knee Pack, REF CETJ130, medical convenience kits
| Date | Jun 15, 2023 (initiated Apr 17, 2023) |
| Status | Open, Classified |
| 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 Regula |
| Quantity | 36 units |
| Distribution | US Distribution to the state of: MA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.