Allen Traction Boot — Class II medical device recall Z-0959-2013
Terminated recall by Allen Medical Systems, Inc., reported 2013-03-27, distributed in AL, GA, IL, KY, NV, NY, OH, PA…. Some units may have been assembled incorrectly which could result in the boot breaking free from the mounting
| Recall number | Z-0959-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Allen Medical Systems, Inc., Acton, MA, United States |
| Recall initiated | 2013-02-28 |
| Classified | 2013-03-18 |
| Reported by FDA | 2013-03-27 |
| Terminated | 2013-08-07 |
| Distributed | AL, GA, IL, KY, NV, NY, OH, PA, TX, WA |
| Countries outside the US | JP, NZ |
| Quantity | 24 devices |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0959-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.