—#89392

Product

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.

FDA product code: KWS — Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K063578
Affected lot / code info: All lots.

Why it was recalled

Firm received complaints of Inclination Set Screws fracturing.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Smith & Nephew Inc
Address: 1450 E. Brooks Rd, Memphis, Tennessee 38116

Distribution

Distribution pattern: Worldwide Distribution: United States, Australia, Austria, Belgium, China, Denmark, France, Germany, Greece, Great Britain, Italy, Netherlands, Poland, Portugal, Spain, Sweden and Switzerland.

Timeline

Recall initiated: 2010-01-14
Posted by FDA: 2010-04-07
Terminated: 2012-04-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #89392. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.