Synthes Small Battery Drive Oscillating Saw Attachment Recall
The Anspach Effort, Inc. is recalling Synthes Small Battery Drive Oscillating Saw Attachments because they may disengage during surgery, posing a risk of injury.
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 (injury to patient/user) 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 12,085 pieces of the Synthes Small Battery Drive (SBD) Oscillating Saw Attachment, Part Number 532.021, used for orthopedic surgery. The recall covers all lots of the product.
The recall is being issued because the oscillating saw attachment has the potential to disengage from the Small Battery Drive handpiece. If this disengagement occurs during a surgical procedure, there is a potential for injury to the patient and/or the user.
The product was distributed worldwide, including nationwide in the United States (including DC, Hawaii, and Puerto Rico) and to numerous international countries. The source text does not specify specific actions for consumers or healthcare providers beyond the recall notice itself.
The recalled product
- Product
- Synthes Small Battery Drive (SBD) Oscillating Saw Attachment Part Number: 532.021 for orthopedic surgery.
- Manufacturer
- The Anspach Effort, Inc.
- Hazard
- Affected units
- 12,085
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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