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Terminated

Reverse Shoulder Prosthesis (RSP) custom device component; RSP RSP 40mm Socket Assembly, Semi-constrained; Custom device manufactured by Encore Medical, L.P., Austin, TX 78758.

FDA Recall Z-1254-2007 · Posted 2007-09-25

Recalling FirmEncore Medical, Lp
Recall StatusTerminated
Product CodeKWS
Date Initiated2007-03-22
Date Terminated2008-03-27
Product Quantity20 units.

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.

Firm Action

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

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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