Recall Z-1395-2024 ยท HSP Splint, Traction
Emergency Products & Research
O.T.D - Optimum Traction Device - Street Orange. Single use traction splint.
| Date | Mar 28, 2024 (initiated Feb 27, 2024) |
| Status | Open, Classified |
| Reason | Failure of adhesive to secure the pole insert. |
| Root cause | Process control |
| Action | Consignees were mailed an URGENT MEDICAL DEVICE RECALL notice, dated 2/27/24. The notice asked consignees who purchased product directly from the recalling firm to examine their inventory for affected devices, quarantine affected devices and discontinue use, and to follow the provided instructions for returning recalled product. Consignees who purchased their recalled devices through a third party are to examine their inventory for affected devices, quarantine affected devices and discontinue use, and contact the seller of the product to coordinate return. If a consignee is unsure of what thir |
| Quantity | 190,000 units |
| Distribution | US Nationwide distribution in the states of CA, CO, FL, GA, IL, IN, KS, MA, MI, NJ, NY, OH, OK, PA, SC, TX, UT, VA, WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.