Reverse Shoulder Prosthesis (RSP) custom device component; 30mm Locking Screw; Custom device manufactured by Encore Medical, L.P., Austin, TX 78758. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Reverse Shoulder Prosthesis (RSP) custom device component; 30mm Locking Screw; Custom device manufactured by Encore Medical, L.P., Austin, TX 78758.
Lot Codes / Batch Numbers
0700-031.
Products Sold
0700-031.
A medical device manufacturer is recalling Reverse Shoulder Prosthesis (RSP) custom device component; 30mm Locking Screw; Custom device manufac due to Marketed without approval: Investigational devices were implanted during an IDE study prior to receiving approval for the devices in the study; patien. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026