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Open, Classified

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

FDA Recall Z-1395-2024 · Posted 2024-03-28

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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