Recall Z-1248-2007 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Encore Medical, Lp
Reverse Shoulder Prosthesis (RSP) custom device component; 32mm Neutral Socket; Custom device manufactured by Encore Medical, L.P., Austin, TX 78758.
| Date | Sep 25, 2007 (initiated Mar 22, 2007) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| 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. |
| Quantity | 20 units. |
| Distribution | Nationwide: Devices sold to and implanted by physicians in CA, CO, FL, GA, NY, SC and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.