FDA Warns Zimmer of Manufacturing Concerns at Trilogy Hip System Facility

WARSAW, Ind. — Zimmer Inc. (NYSE: ZMH) has notified shareholders via an 8-K filing with the Securities and Exchange Commission that it received a warning letter in September from the FDA concerning testing and design-validation procedures at a facility that manufactures the company’s Trilogy Acetabular hip system products.

Zimmer said in its Oct. 1 filing that since the FDA concerns were raised, it has worked to correct issues identified by that agency and that it “is executing a field action to notify customers of the manufacturing issue.”

The SEC requires companies to notify shareholders of significant events via an 8-K …