Device product
Synthes Small Electric Drive (SED)
Z-1017-2016
Product summary
- Event
- Event 69974
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 302 (23 in the USA and 279 OUS)
- Official record key
device-enforcement:Z-1017-2016
Official wording
Reason: May operate solely in reverse mode, not operate in reverse mode when intended, not function or an unintentionally start.
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.
Derived failure modes
-
Unknown
May operate solely in reverse mode, not operate in reverse mode when intended, not function or an unintentionally start.