Reported May 6, 2015 · Terminated

Synthes Small Battery Drive (SBD) Oscillating Saw Attachment Part Number: 532.021 for orthopedic surgery.

The Anspach Effort, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: The Anspach Effort, Inc. · 4500 Riverside Dr · Palm Beach Gardens, FL · 33410-4235

Is this the product you have?

  • Synthes Small Battery Drive (SBD)
  • Oscillating Saw Attachment Part Number532.021 for orthopedic surgery
Lot codes and dates
  • ALL Lots
Amount recalled
12,085 pieces

Where it was sold

Why it was recalled

The potential exists for the Oscillating Saw Attachment to disengage from the Small Battery Drive handpiece. If the attachment disengages from the handpiece intra-operatively, there is a potential for injury to the patient and/or user.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Dec 14, 2016 · Data as of Sep 19, 6:48 PM UTC

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