Synthes Small Electric Drive Recalled for Malfunction and Unintended Operation
The Anspach Effort, Inc. is recalling 599 Synthes Small Electric Drive units because they may malfunction, fail to operate, 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 failure) where no specific injuries or illnesses have been reported in the source text, fitting the High severity criteria for risk-of-harm products without reported injury.
Plain-English summary
The Anspach Effort, Inc. is recalling 599 units of the Synthes Small Electric Drive (SED), a device used in general traumatology. The recall covers all lots of the product.
The recall was issued because the affected devices may operate solely in reverse mode, fail to operate in reverse mode when intended, not function at all, or start unintentionally. These malfunctions pose a risk of injury to patients or medical professionals during use.
The product was distributed worldwide, including in the United States (nationwide, including AR, AZ, CA, CO, FL, ID, IL, KS, LA, MI, NC, NY, TX, WA, VA, and HI) and numerous international locations. Users should stop using the device and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- Synthes Small Electric Drive (SED). For use in general traumatology.
- Manufacturer
- The Anspach Effort, Inc.
- Affected units
- 599
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
Distribution
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