Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Optimum Traction Device

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Optimum Traction Device see related information
Date Initiated by Firm February 27, 2024
Date Posted March 28, 2024
Recall Status1 Open3, Classified
Recall Number Z-1395-2024
Recall Event ID 94207
Product Classification Splint, traction - Product Code HSP
Product O.T.D - Optimum Traction Device - Street Orange. Single use traction splint.
Code Information Model EP-800; Lot No. 20230523-04, 09082023-11, 09082023-12, 122023-3, 122023-2, 122023-1.
Recalling Firm/
Manufacturer		 Emergency Products & Research
890 W Main St
Kent OH 44240-2284
For Additional Information Contact Colleen Gilman
+1-315-3523948
Manufacturer Reason
for Recall		 Failure of adhesive to secure the pole insert.
FDA Determined
Cause 2		 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 EPRinfo@epandr.com. 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
-
-