CarboFix Orthopedics, Ltd - March 2, 2017
Issue Date
Mar 02, 2017
Region
HQ
Category
Device
$117.00
Contact Name
Mordechay Beyar
Contact Title
President
Address 1
11 Ha, Hoslim St.
City
Herzliya, Hamerkaz
Zip/Postal Code
46724
Country
Israel
Inspection Range
Feb 27, 2017 - Mar 02, 2017
Pages
3
First Observation
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
Investigator(s): Ronald Ifraimov and Edward E. Lockwood