Device Recall Reverse Shoulder Prosthesis device components 의 리콜

Recall

37874

Class 2

Z-1258-2007

2007-03-22

2007-09-25

Terminated

United States

2008-03-27

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=55395

Marketed without approval: investigational devices were implanted during an ide study prior to receiving approval for the devices in the study; patients were implanted with investigational devices outside of the ide study; and devices implanted as "custom devices" by the manufacturer did not meet the definition of "custom devices" and were, therefore, unapproved devices.

Letters were sent via Certified Mail on 03/22/07 to the surgeons and their associated IRBs. Each letter included a list of the patients to be notified and a form letter that the surgeons could use to notify the patients. Surgeons asked to notify their patients and to provide Encore with documented evidence that patience were notified.