RecallRadar

FDA Device recall Z-0959-2013

Allen Traction Boot, Modular, OT 1000 Traction Device Boot Assembly, Fracture Table Orthopedic Leg Holders, non-invasive medical devices de…

On 2013-03-27 the FDA classified a Class II recall of Allen Traction Boot, Modular, OT 1000 Traction Device Boot Assembly, Fracture Table Orthopedic Leg Holders, non-invasive medical devices de… by Allen Medical Systems, citing 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.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0959-2013
ClassificationClass II
Statusterminated
Initiated2013-02-28
Published2013-03-27
Last updated2026-09-13 11:53 UTC
CompanyAllen Medical Systems
DistributionAL, GA, IL, KY, NV, NY, OH, PA, TX, WA

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.

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.

Identifiers

code_info
A260264, A253312, A260989, A260262, 418292, A260991, A260998, A253313, A260993, A260265, 418293, A253309, A260995, A253…A260264, A253312, A260989, A260262, 418292, A260991, A260998, A253313, A260993, A260265, 418293, A253309, A260995, A253310, A260992, A253311, 418294, A253323, A260261, A253321, A260994, 418291, 418295, A253322

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0959-2013%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.