Recall Z-0865-2022 ยท OJH Orthopedic Tray
Stradis Medical, LLC dba Stradis Healthcare
Anterior Hip Pack - Surgical Kit
| Date | Feb 25, 2022 |
| Status | Open, Classified |
| Reason | The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit. |
| Root cause | Process change control |
| Action | A copy of the final recall letter was sent to all affected consignees via 1st class USPS mail on February 25, 2022. The consignees were instructed that the use of further distribution of the potentially perforated kits should immediately cease. Instructions were provided to return any unused Surgical Kits with the scope of this recall to Stradis Healthcare s facility in Georgia. Periodic effectiveness checks will be conducted in order to follow-up with consignees to ensure effectiveness. |
| Quantity | 100 units |
| Distribution | US Nationwide distribution in the states of IN, TX, and PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.