Recall Z-0801-2011 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Encore Medical, Lp
Turon Shoulder System Instrumentation, Turon Pegged Glenoid Drill Guide, REF 804-25-024, DJO Surgical
| Date | Dec 22, 2010 (initiated Nov 5, 2010) |
| Status | Terminated |
| Reason | Complaints of fracturing were reported for affected trial products. |
| Root cause | Device Design |
| Action | Encore Medical notified consignees by letter on 11/5/2010. |
| Quantity | 34 units |
| Distribution | TX, FL, SC, GA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080402 | ENCORE SHOULDER PRIMARY HUMERAL STEM, MODEL 500-00, ENCORE SHOULDER HUMERAL HEAD, MODEL 520-38 Encore Medical L.P., Mar 28, 2008 |