Reverse Shoulder Prosthesis (RSP) custom device component; 32mm RSP Glenoid Baseplate; Custom device manufactured by Enc

FDA device recall Z-1249-2007 · posted 2007-09-25 · Terminated

Recall details

Recalling firm

Encore Medical, Lp

Reason for recall

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.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

KWS

Quantity affected

20 units.

Distribution

Nationwide: Devices sold to and implanted by physicians in CA, CO, FL, GA, NY, SC and TX.

Date initiated

2007-03-22

Date posted

2007-09-25

Date terminated

2008-03-27

Location

Austin, TX