Allen Medical Systems, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0959-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: February 28, 2013

Date Posted: March 27, 2013

Recall Number: Z-0959-2013

Event ID: 64509

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.

Status: Terminated

Product Quantity: 24 devices

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.

Voluntary or Mandated:

Voluntary: Firm initiated