Reported Mar 27, 2013 · Terminated
Allen Traction Boot, Modular, OT 1000 Traction Device Boot Assembly, Fracture Table Orthopedic Leg Holders,…
Allen Medical Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Allen Medical Systems, Inc. · One Post Office Square · Acton, MA · 01720
Is this the product you have?
- 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.
- Lot codes and dates
A260264A253312A260989A260262418292A260991A260998A253313A260993A260265418293A253309A260995A253310A260992A253311418294A253323A260261A253321A260994418291418295A253322
- Amount recalled
- 24 devices
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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