Recall Z-0959-2013— Allen Medical Systems, Inc.
Class II · Terminated
Class II FDA medical device recall by Allen Medical Systems, Inc., initiated 2013-02-28, terminated 2013-08-07. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Allen Medical Systems, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-02-28
- Terminated
- 2013-08-07
- Firm location
- Acton, MA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.