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Allen Medical Systems, Inc. recalls Allen Traction Boot, Modular, OT 1000 Traction Device Boot Assembly, Fracture Table Orthopedic Leg Holders, non-invasiv
Recalled March 27, 2013 · FDA recall Z-0959-2013 · Allen Medical Systems
Hazard
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. · FDA Class II
Units
24 devices
Sold at
Worldwide Distribution- USA including the states of TX, NV, KY, GA, OH, PA, NY, AL, WA, IL and the countries of New Zealand and Japan.
Description
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.
Product
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.
Manufacturer(s)
Allen Medical Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →