Food, drugs, devices › Allen Medical Systems, Inc.
Device recall: Allen Traction Boot, Modular, OT 1000 Traction Device Boot Assembly, Fracture Table Orthopedic Leg Holders, non-invasive
FDA enforcement event 64509 is a device recall by Allen Medical Systems, Inc. of Acton, MA, initiated 28 Feb 2013 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 90% of the 1,236 device enforcement events initiated in 2013 carry the same class.
Status: Terminated, terminated 7 Aug 2013. Initiation: voluntary: firm initiated. Allen Medical Systems, Inc. has 3 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Allen Medical Systems, Inc., Acton, MA.
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."
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 records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0959-2013 | 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. | 24 devices | Class II | Terminated | 27 Mar 2013 |
Context
Other enforcement events for Allen Medical Systems, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 3 Jan 2017 | Arthrex Shoulder Suspension Tower; Catalog Number: AR-1650-01 Product Usage: The Arthrex Lateral Decubitus Shoulder Posi | Device | Class II | 1 |
| 23 Nov 2016 | Arthex S3 Arm Sleeve Connector; Catalog Number AR-1650-02; manufactured and distributed between March and November 2016. | Device | Class II | 1 |
All 3 events for Allen Medical Systems, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall 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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "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."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 7 Aug 2013. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.