Recall Z-0693-2022 ยท OJH Orthopedic Tray
ROi CPS LLC
Regard, TOTAL HIP - SPRINGFIELD, Item No. 8800297010, Case Quantity: 2, Sterile
| Date | Jan 13, 2022 |
| Status | Terminated |
| Reason | Products are mislabeled with the incorrect product identification on individual kit labeling. |
| Root cause | Under Investigation by firm |
| Action | The firm emailed a recall notification to customers on 01/13/2022 tited "ROi CPS, LLC Recall-Custom Procedure Kit Recall-Kits Containing the Incorrect Product Label." The recall notice states that the reason for recall is due to the individual kits being incorrectly labeled, while the outer box is labeled correctly. The outer box was labeled with Product No. 880297010, while the inner kit bags were labeled as Product No. 880261009. Customers are directed to review their inventory to determine if recalled kits are in stock and quarantine any identified recalled product. The firm instructs custo |
| Quantity | 50 kits |
| Distribution | Missouri |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.