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Recall Observatory FDA recall evidence

Device 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.

Z-2784-2016

June 24, 2016

Class I

Product summary

Firm
The Anspach Effort, Inc.
Event
Event 74835
Status
Terminated
Classification
Class I
Quantity
1,833 devices (05.001.024 and 05.001.108)
Official record key
device-enforcement:Z-2784-2016

Official wording

Reason: 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.

Code information: Model/Catalog: Adapter for Small Battery Drive and Small Battery Drive II for Electric Pen Drive 05.001.024; Lot/Set/Serial: All Manufactured Lots/Serial Numbers.

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.