FDA recall Z-1395-2024

Product

O.T.D - Optimum Traction Device - Street Orange. Single use traction splint.

Reason for recall

Failure of adhesive to secure the pole insert.

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.

Key facts

Status

Ongoing

Initiation date

2024-02-27

Report date

2024-04-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Kent, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1395-2024