Synthes Small Electric Drive Recalled for Malfunction and Unintended Operation
The Anspach Effort, Inc. is recalling 302 Synthes Small Electric Drive units because they may malfunction or start unintentionally.
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 medical device with a risk of harm (unintended operation or malfunction) where specific injury reports are not detailed in the source text, fitting the criteria for a High severity rating.
Plain-English summary
The Anspach Effort, Inc. is recalling 302 units of the Synthes Small Electric Drive (SED). The recall covers 23 units in the United States and 279 units outside the United States. The affected units are distributed across multiple U.S. states and numerous international locations.
The recall is being conducted because the devices may operate solely in reverse mode, fail to operate in reverse mode when intended, fail to function, or start unintentionally. These malfunctions pose a risk of injury to patients or operators during use.
Healthcare providers and consumers should stop using the affected devices immediately and contact The Anspach Effort, Inc. for further instructions on repair, replacement, or return.
The recalled product
- Product
- Synthes Small Electric Drive (SED)
- Manufacturer
- The Anspach Effort, Inc.
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 (1)
- All lots from production launch
Distribution
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