Recall Z-1242-2010 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Smith & Nephew Inc
PROMOS Inclination set, SIZE 26mm, REF 42 186, S&N 75006725, QTY: (1), STERILE R, Smith & Nephew Orthopaedics AG, CH-Rotkreuz-Switzerland. The device is used as a semi-constrained, metal/polymer cemented shoulder prosthesis.
| Date | Apr 7, 2010 (initiated Jan 14, 2010) |
| Status | Terminated |
| Reason | Firm received complaints of Inclination Set Screws fracturing. |
| Root cause | Device Design |
| Action | All affected Smith & Nephew Sales Representatives were notified of problem and the recall overnight mail on January 23, 2009. All affected Smith & Nephew International Distributors were notified via email and telephone on January 23, 2009. They were instructed to immediately quarantine the product for return to Stericycle, Inc., 2670 Executive Dr. Suite A Indianapolis, IN 46241. Direct questions to Smith & Nephew, Inc. by calling 1-901-399-6153. |
| Quantity | 362 units |
| Distribution | Worldwide Distribution: United States, Australia, Austria, Belgium, China, Denmark, France, Germany, Greece, Great Britain, Italy, Netherlands, Poland, Portugal, Spain, Sweden and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063578 | PROMOS MODULAR SHOULDER SYSTEM Plus Orthopedics AG, Mar 2, 2007 |