O.T.D - Optimum Traction Device - Street Orange. Single use traction splint.
FDA Recall Z-1395-2024 · Posted 2024-03-28
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Recalling FirmEmergency Products & Research
Recall StatusOpen, Classified
Product CodeHSP
Date Initiated2024-02-27
Product Quantity190,000 units
Reason for Recall
Failure of adhesive to secure the pole insert.
Firm 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 third party a device was purchased from, they are to contact the recalling firm at 1-330-673-5003 or by email at [email protected]. Customers may contact the recalling firm between the hours of 8:00 AM and 3:00 PM EST.
Root Cause
Process control
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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