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
Product summary
- 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
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.