Device product
O.T.D - Optimum Traction Device - Street Orange. Single use traction splint.
Z-1395-2024
Product summary
- Event
- Event 94207
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 190,000 units
- Official record key
device-enforcement:Z-1395-2024
Official wording
Reason: Failure of adhesive to secure the pole insert.
Code information: Model EP-800; Lot No. 20230523-04, 09082023-11, 09082023-12, 122023-3, 122023-2, 122023-1.
Distribution pattern: 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.
Derived failure modes
-
Unknown
Failure of adhesive to secure the pole insert.