Allen Medical Systems Recalls Traction Boots Due to Assembly Defect
Allen Medical Systems is recalling 24 traction boots because incorrect assembly could cause the boot to detach, allowing a patient's leg to fall during surgery.
The agency’s classification
FDA (Devices): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Allen Medical Systems, Inc. is recalling 24 units of the Allen Traction Boot, Modular, OT 1000 Traction Device Boot Assembly, and Fracture Table Orthopedic Leg Holders. These non-invasive medical devices are designed to attach to orthopedic fracture tables to help clinical staff apply traction to a patient's leg during surgical procedures.
The recall is being issued because some units may have been assembled incorrectly. This defect could result in the boot breaking free from the mounting base, which would allow the patient's leg to fall.
The affected devices were distributed worldwide, including in the United States (specifically in Texas, Nevada, Kentucky, Georgia, Ohio, Pennsylvania, New York, Alabama, Washington, and Illinois) and in New Zealand and Japan. Specific lot codes for the recalled units are listed in the agency's official records.
The recalled product
- 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…
- Manufacturer
- Allen Medical Systems, Inc.
- Affected units
- 24
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- A260264
- A253312
- A260989
- A260262
- 418292
- A260991
- A260998
- A253313
- A260993
- A260265
- 418293
- A253309
- A260995
- A253310
- A260992
- A253311
- 418294
- A253323
- A260261
- A253321
Distribution
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