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.
Recall
- Recall Number
- Z-0959-2013
- Event Number
- 64509
- Firm
- Allen Medical Systems, Inc. One Post Office Square
- FEI Number
- 1221538
- Product Code
- HST
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- February 28, 2013
- Posted
- March 18, 2013
- Terminated
- August 7, 2013
- Address
- Acton, MA, 01720
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.
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.
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.
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.
24 devices