Recall Z-1438-2023 ยท OJH Orthopedic Tray
ROi CPS LLC
Sterile surgical convenience kits: 1. regard Item Number: 880473001, OR01105A - Total Shoulder/Hip; 2. regard Item Number: 880426004, OR01033D - Total Hip; 3. regard Item Number: 880427003, OR01034C - Total Knee; 4. regard Item Number: 880474001, OR01106A - Knee Arthroscopy; 5. regard Item Number: 800772006, OR00977F - OH Total Knee Pack ; 6. regard Item Number: 880403004, OR01009D
| Date | Apr 25, 2023 (initiated Mar 22, 2023) |
| Status | Open, Classified |
| Reason | The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component. |
| Root cause | Nonconforming Material/Component |
| Action | The recalling firm issued letters dated 3/22/2023 via email the same day. The letter explained the issue, identified the affected product, and listed the actions to be taken by the customer. The actions included checking their inventory for the affected product, segregate and quarantine all affected kits in their inventory, and use the attached label template to print warning labels to be affixed to all affected kits in their inventory. The label should be applied to each affected kit and outer product case in a prominent location to end users of the kits. The location chosen should not co |
| Quantity | 1,369 kits |
| Distribution | US Nationwide distribution in the states of FL and MO. There was no foreign/military/government distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.