Z-0959-2013 Class II Terminated
FDA device recall Z-0959-2013 was initiated by Allen Medical Systems, Inc. on February 28, 2013 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated August 7, 2013). Affected quantity: 24 devices.
Recall Details
- Product Type
- Devices
- Report Date
- March 27, 2013
- Initiation Date
- February 28, 2013
- Termination Date
- August 7, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24 devices
Product Description
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.
Reason for Recall
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.
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.
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