Zimmer Confirms Ongoing FDA Attention To Warsaw Plant
Zimmer Biomet saw increased growth during the second quarter – but the company also confirmed on its recent Q2 earnings call that its quality remediation efforts continue, with fresh FDA observations arising from the agency's most recent inspection of one of Zimmer's Indiana-based manufacturing facilities.
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US FDA has released a six-violation warning letter sent to a Zimmer Biomet facility in Warsaw, Ind. The company had already acknowledged that the letter was a possibility.
The top four orthopedic implant makers have released their second-quarter and half-year results. Following DePuy Synthes report of a still-soft but recovering reconstructive implant market, this edition of Earnings Winners And Losers look at how the other three big recon players – Zimmer Biomet, Stryker, and Smith & Nephew fare. It also offers a peek into the top- and bottom-line results of the other key names within Medtech Insight's Top 10 orthopedic companies.
A follow-up inspection evaluating Zimmer Biomet’s progress in remediating issues documented in a 2016 FDA Form-483 uncovered 11 observations, eight of them repeats.