Recall Z-0961-2009 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Smith & Nephew Inc
PROMOS Reverse, Glenosphere Loosening Adapter, REF 24 000 047, S&N 75005271, Rx only, QTY(1), non-sterile Instrument for prosthesis, shoulder, semi-constrained, metal/polymer cementer
| Date | Feb 3, 2009 (initiated Nov 21, 2008) |
| Status | Terminated |
| Reason | The product was breaking during use. |
| Root cause | Other |
| Action | All affected Smith & Nephew International Distributors were notified via email on 11/21/2008. They were instructed to immediately notify their accounts concerning the recall. Contact Smith & Nephew Inc at 901-399-6771 for assistance. |
| Quantity | 51 units |
| Distribution | Germany, France, Italy Austria, Switzerland, Belgium, United Kingdom, Greece, Australia, South Africa, Spain, and Cypress |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081016 | SMITH & NEPHEW, INC., PROMOS REVERSE SHOULDER SYSTEM Smith & Nephew, Inc., Sep 5, 2008 |