The Anspach Effort, Inc.: Medical Device Recall in 2016 - (Recall #: Z-1017-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Synthes Small Electric Drive (SED)

Product Classification:

Class II

Date Initiated: November 14, 2014

Date Posted: March 2, 2016

Recall Number: Z-1017-2016

Event ID: 69974

Reason for Recall:

May operate solely in reverse mode, not operate in reverse mode when intended, not function or an unintentionally start.

Status: Ongoing

Product Quantity: 302 (23 in the USA and 279 OUS)

Code Information:

All lots from production launch

Distribution Pattern:

CO, FL, LA, ID, CA, KS, IL, TX, VA, MI, NC, WA, AR, NY, NC, AZ, and Hawaii Canada, Hong Kong, Chile, Israel, Poland, Turkey, Itly, Malaysia, Ireland, Korea, Germany, Spain, Norway, Sweeden, England, Fiji, Switzerland, Belgium, Austria, Netherlands, France, Japan, China, India, Thailand, Russia, Zaire, Taiwan, and Australia.

Voluntary or Mandated:

Voluntary: Firm initiated