Sulzer Orthopedics Inter-Op
This article was originally published in The Gray Sheet
Executive Summary
Recall of acetabular shells for hip replacement affects roughly 17,750 devices implanted in the U.S. after October 1999, the company announces Dec. 8. Testing of the manufacturing process showed a low percentage of components having a residue of lubricant on the exterior porous surface, which may cause aseptic loosening of the shell, Sulzer explains. "Only a very small number of patients who have received one of these shells may require medical intervention other than post-operative monitoring," the firm says