FDAFDA · Food and drugs·Recall number Z-0959-2013
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.
Published March 27, 2013 · Recall initiated: February 28, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Allen Medical Systems, Inc.
- Distributor
- 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.
- Lot
- A260264, A253312, A260989, A260262, 418292, A260991, A260998, A253313, A260993, A260265, 418293, A253309, A260995, A253310, A260992, A253311, 418294, A253323, A260261, A253321, A260994, 418291, 418295, A253322
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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