Z-1017-2016 Class II Ongoing
FDA device recall Z-1017-2016 was initiated by The Anspach Effort, Inc. on Nov 14, 2014 and is designated Class II. Reason for recall: May operate solely in reverse mode, not operate in reverse mode when intended, not function or an unintentionally start. The recall status is ongoing. Affected quantity: 302 (23 in the USA and 279 OUS).
Recall Details
- Product Type
- Devices
- Report Date
- Mar 2, 2016
- Initiation Date
- Nov 14, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 302 (23 in the USA and 279 OUS)
Product Description
Synthes Small Electric Drive (SED)
Reason for Recall
May operate solely in reverse mode, not operate in reverse mode when intended, not function or an unintentionally start.
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.
Code Information
All lots from production launch
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1017-2016
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026