Z-0959-2013Class II

Allen Traction Boot, Modular, OT 1000 Traction Device Boot Assembly, Fracture Table Orthopedic Leg Holders...

Name: Z-0959-2013 Allen Traction Boot, Modular, OT 1000 Traction Device Boot Assembly, Fracture Table Orthopedic Leg Holders...
Creator: Allen Medical Systems, Inc.
Published: 2013-02-28
License: https://open.fda.gov/license/

Allen Medical Systems, Inc. / initiated 2013-02-28 / Terminated / root cause: manufacturing process

FDA source

Allen Medical Systems, Inc. began a recall of Allen Traction Boot, Modular, OT 1000 Traction Device Boot Assembly, Fracture Table Orthopedic Leg Holders, non-invasive medical devices designed to attach to... on 2013-02-28. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0959-2013
Classification: Class II
Status: Terminated
Initiated: 2013-02-28
Posted: 2013-03-18
Terminated: 2013-08-07
Recalling firm: Allen Medical Systems, Inc.
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.
Product code: HST Apparatus, Traction, Non-Powered
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Allen Medical Systems sent a "Urgent Medical Device Recall" letter dated February 28, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken. Customers were instructed to: 1. Immediately remove from service your Allen Traction Boot with the serial number(s) XXXXX 2. Contact Allen Medical Customer Service at (800) 433-5774 for an RMA number and instructions to return your Allen Traction Boot for inspection and repair if necessary. There will be no cost to you. 3. Return your Allen Traction Boot to Allen Medical as soon as possible. In order to minimize the inconvenience, we will repair your Allen Traction Boot and return the device to you within 48 hours of receipt.
Quantity in commerce: 24 devices
Distribution: 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.
Product codes and lots: A260264, A253312, A260989, A260262, 418292, A260991, A260998, A253313, A260993, A260265, 418293, A253309, A260995, A253310, A260992, A253311, 418294, A253323, A260261, A253321, A260994, 418291, 418295, A253322

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0959-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0959-2013	Class II	Terminated	Voluntary: Firm initiated	2013-03-27	2013-03-18

Product code HST

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)