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Recall Observatory FDA recall evidence

Device 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.

Z-0959-2013

February 28, 2013

Class II

Product summary

Firm
Allen Medical Systems, Inc.
Event
Event 64509
Status
Terminated
Classification
Class II
Quantity
24 devices
Official record key
device-enforcement:Z-0959-2013

Official wording

Reason: 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.

Code information: A260264, A253312, A260989, A260262, 418292, A260991, A260998, A253313, A260993, A260265, 418293, A253309, A260995, A253310, A260992, A253311, 418294, A253323, A260261, A253321, A260994, 418291, 418295, A253322

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.

Field note

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