Z-1395-2024Class II

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

Name: Z-1395-2024 O.T.D - Optimum Traction Device - Street Orange. Single use traction splint
Creator: Emergency Products & Research
Published: 2024-02-27
License: https://open.fda.gov/license/

Emergency Products & Research, Inc. / initiated 2024-02-27 / Open, Classified / root cause: manufacturing process

FDA source

Emergency Products & Research began a recall of O.T.D - Optimum Traction Device - Street Orange. Single use traction splint on 2024-02-27. FDA classified it as Class II and gives the reason as "Failure of adhesive to secure the pole insert". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1395-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-02-27
Posted: 2024-03-28
Recalling firm: Emergency Products & Research, Inc.
Product: O.T.D - Optimum Traction Device - Street Orange. Single use traction splint.
Product code: HSP Splint, Traction
Reason for recall: Failure of adhesive to secure the pole insert.
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 190,000 units
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.
Product codes and lots: Model EP-800; Lot No. 20230523-04, 09082023-11, 09082023-12, 122023-3, 122023-2, 122023-1.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1395-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1395-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-03	2024-03-28

Product code HSP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)