Z-0747-2016 Class II Terminated

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

FDA device recall Z-0747-2016 was initiated by The Anspach Effort, Inc. on Aug 14, 2014 and is designated Class II. Reason for recall: The affected Small Electric Drive (SED) may operate solely in reverse mode, not operate in reverse mode when intended, not function, or unintentionally start. The recall status is terminated (terminated Feb 5, 2016). Affected quantity: 599 each.

Recall Details

Product Type
Devices
Report Date
Feb 10, 2016
Initiation Date
Aug 14, 2014
Termination Date
Feb 5, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
599 each

Product Description

Synthes Small Electric Drive (SED). For use in general traumatology.

Reason for Recall

The affected Small Electric Drive (SED) may operate solely in reverse mode, not operate in reverse mode when intended, not function, or unintentionally start.

Distribution Pattern

Worldwide Distribution-US (nationwide) including the states of AR, AZ, CA, CO, FL, ID, IL, KS, LA, MI, NC, NY, TX, WA, VA and HI, and the countries of Germany, Hong Kong, Chile, Israel, Poland, Italy, Turkey, Italy, Singapore, Ireland, Korea, Spain, Norway, Denmark, Great Britain, Finland, Belgium, Netherlands, France, Japan, Sweden, Switzerland, Austria, China, India, Thailand, Russia, New Zealand, Zaire, Australia, Taiwan, and Malaysia.

Code Information

All Lots

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-0747-2016
openFDA file date
Oct 26, 2026
Loaded by RegDataLab
Oct 27, 2026

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