Zimmer Garners Warning Letter Over Quality Deficiencies

Zimmer Biomet had hinted at a warning letter in an SEC filing last month but revealed little details about the exact nature of the deficiencies uncovered at the firm’s facility in Montreal, Canada.

Posted to the FDA’s website on July 11, the letter revealed numerous serious quality system deficiencies, including CAPA, complaint handling, supplier audits, medical device reporting and maintaining adequate records.

The Canadian facility is the principal location for Zimmer’s wholly owned subsidiary ORTHOsoft. — Tamra Sami