The Anspach Effort, Inc. Synthes Small Electric Drive (SED) Recall
Class II: 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
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Synthes Small Electric Drive (SED)
Brand
The Anspach Effort, Inc.
Lot Codes / Batch Numbers
All lots from production launch
Products Sold
All lots from production launch
The Anspach Effort, Inc. is recalling Synthes Small Electric Drive (SED) due to May operate solely in reverse mode, not operate in reverse mode when intended, not function or an unintentionally start.. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
May operate solely in reverse mode, not operate in reverse mode when intended, not function or an unintentionally start.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, AR, CA, CO, FL, HI, ID, IL, KS, LA, MI, NY, NC, TX, VA, WA
Page updated: Jan 10, 2026