PlainRecalls
FDA Devices Critical Class I Terminated

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.

Reported: October 5, 2016 Initiated: June 24, 2016 #Z-2784-2016

Product Description

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.

Reason for Recall

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.

Details

Recalling Firm
The Anspach Effort, Inc.
Units Affected
1,833 devices (05.001.024 and 05.001.108)
Distribution
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.
Location
Palm Beach Gardens, FL

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by The Anspach Effort, Inc.. Units affected: 1,833 devices (05.001.024 and 05.001.108).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 5, 2016. Severity: Critical. Recall number: Z-2784-2016.

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