Reported Oct 5, 2016 · Terminated

Adaptor for Small Battery Drive and Small Battery Drive II. Product Usage: The Light Adaptor for Small Battery Drive…

The Anspach Effort, Inc.

High riskUsing this product could cause serious injury, illness or death — stop using it now.

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?

  • Adaptor for Small Battery Drive and Small Battery Drive II
  • Product UsageThe Light Adaptor for Small Battery Drive (SBD) /Small Battery Drive II (SBD II) is designed for use in traumatology and orthopedic surgery of the skeleton, i.e. drilling, reaming or cutting bone. The Adaptors (05.001.024 and 05.001.108) can be used with one of the electrical consoles belonging to the Electric Pen Drive (EPD) to operate the Small Battery Drive and Small Battery Drive II
Lot codes and dates
  • Model/CatalogAdapter for Small Battery Drive and Small Battery Drive II for Electric Pen Drive 05.001.024
  • Lot/Set/SerialAll Manufactured Lots/Serial Numbers
Amount recalled
1,833 devices (05.001.024 and 05.001.108)

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

  • Nationwide

Why it was recalled

Stop using this product now

There was a potential for the Adaptor and Light Adaptor for Small Battery Drive and Small Battery Drive II to generate excessive internal pressure that may cause the products to burst.

Using this product could cause serious injury, illness or death — stop using it now.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 9, 2018 · Data as of Sep 19, 6:03 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.