U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Orthofix is conducting a voluntary recall of the connector system large set screw (pn: 79-2002) with affected lot numbers 001 and 002, and small set screw (pn: 79-2003) with affected lot numbers 002, 003 and 004. through the company's manufacturing controls, size discrepancies were noted with the drive feature for both the large and small sets screws. as a result, it is possible that (1) the set screw drive feature will not accept the set screw driver (pn: 79-1006) or
(2) the driver may get wedged in the corners of the drive feature (false bottom) which may lead to a stripped set screw.
조치
The firm disseminated the recall notices on 02/23/2018 by mail. The firm requested the return of the screws.