FDA Enforcement
Class II
Ongoing
O.T.D - Optimum Traction Device - Street Orange. Single use traction splint.
Recall: Z-1395-2024
·
Reported April 3, 2024
Enforcement
- Recall Number
- Z-1395-2024
- Event ID
- 94207
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Emergency Products & Research
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 3, 2024
- Initiation Date
- February 27, 2024
- Classification Date
- March 28, 2024
- Address
- 890 W Main St, N/A, Kent, OH, 44240-2284, United States
Description
O.T.D - Optimum Traction Device - Street Orange. Single use traction splint.
Reason
Failure of adhesive to secure the pole insert.
Code Info
Model EP-800; Lot No. 20230523-04, 09082023-11, 09082023-12, 122023-3, 122023-2, 122023-1.
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.
Quantity
190,000 units