The Anspach Effort, Inc. recalls Adaptor for Small Battery Drive and Small Battery Drive II. Product Usage: The Light Adaptor for Small Battery Drive

Recalled October 5, 2016 · FDA recall Z-2784-2016 · The Anspach Effort

Hazard

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. · FDA Class I

Units

1,833 devices (05.001.024 and 05.001.108)

Sold at

Worldwide Distribution - US Nationwide and including the countries of Canada, Austria, Australia, Belgium, Brazil, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Libya, Malaysia, Mexico, Nepal, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovenia, Slovakia, Spain, South Africa, South Korea, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and Vietnam, and areas of Middle East, Africa, Asia & Pacific.

Description

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.

Product

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

Manufacturer(s)

The Anspach Effort, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →