FDA-Device2016-10-05Class I
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.
The Anspach Effort, Inc.
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.
Sold states
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.
Affected count
1,833 devices (05.001.024 and 05.001.108)
Manufactured in
4500 Riverside Dr, N/A, Palm Beach Gardens, FL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2784-2016Don't want to check this manually?
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