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[Recalled] Synthes Small Electric Drive (SED). For use in general traumatology. — The affected Small Electric Drive (SED) may operate solely in reverse mode, not… | FDA 2014-08-14

recall fda device united-states

Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.

Recall details

ProductSynthes Small Electric Drive (SED). For use in general traumatology.
Brand / manufacturerThe Anspach Effort, Inc.
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-0747-2016
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date14 August 2014

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: The affected Small Electric Drive (SED) may operate solely in reverse mode, not operate in reverse mode when intended, not function, or unintentionally start.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from The Anspach Effort, Inc.

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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