Recall Z-0185-2008 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Encore Medical, Lp
Encore Reverse Shoulder Prosthesis (RSP) System, Standard Size 40 RSP Humeral Socket Insert; Catalog #: 508-00-040; Sterile; Manufactured by Encore, Medical, L.P., Austin, TX 78758.
| Date | Dec 19, 2007 (initiated Aug 8, 2007) |
| Status | Terminated |
| Reason | Devices Mislabeled; one lot of Size 36 Standard RSP Socket Inserts were labeled as Size 40 Standard RSP Sockets and vice versa. |
| Root cause | Other |
| Action | Encore notified their sales reps (direct accounts) via telephone and overnight letter on 08/08/07. Encore sales reps were asked to return all outstanding devices, for which they would be given replacements. Notification of implanting surgeons was done by phone and letter (Urgent : Device Recall) between 08/07 and 09/12/07. Implanting surgeons notified of recall and asked to closely monitor patients who had received and already been implanted with the affected lots. If explant was required decision of the surgeons, they were asked to notify the recalling firm. |
| Quantity | 25 units. |
| Distribution | Nationwide:Direct accounts and surgeons in the following states: CA, GA, IA, MA, MD, MI, MO, SC, TX and UT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041066 | ENCORE REVERSE SHOULDER PROSTHESIS Encore Medical L.P., Mar 24, 2005 |