Home / Recalls / The Anspach Effort, Inc. / Z-2784-2016

Z-2784-2016 Class I Terminated

Recalled by The Anspach Effort, Inc. — Palm Beach Gardens, FL

FDA device recall Z-2784-2016 was initiated by The Anspach Effort, Inc. on Jun 24, 2016 and is designated Class I. 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. The recall status is terminated (terminated Jun 9, 2018). Affected quantity: 1,833 devices (05.001.024 and 05.001.108).

Recall Details

Product Type: Devices
Report Date: Oct 5, 2016
Initiation Date: Jun 24, 2016
Termination Date: Jun 9, 2018
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1,833 devices (05.001.024 and 05.001.108)

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.

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.

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.

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-2784-2016
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 26, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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