Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Allen Traction Boot Recalled by Allen Medical Systems, Inc. Due to Some units may have been assembled incorrectly which...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Allen Medical Systems, Inc. directly.
Affected Products
Allen Traction Boot, Modular, OT 1000 Traction Device Boot Assembly, Fracture Table Orthopedic Leg Holders, non-invasive medical devices designed to attach to orthopedic fracture tables to aid clinical staff in applying traction to the leg of a patient during surgical procedures.
Quantity: 24 devices
Why Was This Recalled?
Some units may have been assembled incorrectly which could result in the boot breaking free from the mounting base and allowing the patient's leg to fall.
Where Was This Sold?
This product was distributed to 10 states: AL, GA, IL, KY, NV, NY, OH, PA, TX, WA
About Allen Medical Systems, Inc.
Allen Medical Systems, Inc. has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report