Smith & Nephew, Inc. recalls Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING FEMORAL HEAD, STERILE R, Rx only, REF Numbers: 74121138 (38 MM), 7412314…

Recall date

June 3, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2745-2015

FDA classification

Class II

Brand / firm

Smith & Nephew, Inc.

Sold / distributed

Worldwide Distribution - US Nationwide and countries of: Australia, Austria, Bahrain (UAE), Belgium, Canada, China, Denmark, Finland, Germany, Hong Kong, Italy, Japan, Malaysia, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzer…

Why it was recalled

The firm observed that the BIRMINGHAM HIP(TM) Resurfacing (BHR) System had revision rates which were higher than established benchmarks.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING FEMORAL HEAD, STERILE R, Rx only, REF Numbers: 74121138 (38 MM), 74123140 (40 MM), 74121142 (42 MM), 74123144 (44 MM), 74121146 (46 MM). Product Usage: Hip joint prosthesis