The Recall Desk
HighFDA (Devices)·Z-1553-2015·Announced 2015-05-06

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.

What this means for you

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.
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

Distributed nationwide across the United States.

The notice also names 3 states specifically: