According to several news outlets, Zimmer Holdings Inc. received a notice letter from the FDA regarding complications manufacturing and testing an artificial hip device. The warning letter sent on September 19, 2012, followed regulatory inspection of the plant in June.
About the FDA Warning
- According to Fierce Medical Devices, the letter was regarding Zimmer Holdings’ Trilogy Acetabular System device.
- FDA inspectors were bothered that Zimmer had no testing instrument to show Trilogy products coordinated with pre-determined design stipulations.
- Zimmer’s response was notifying its customers of the manufacturing issues. It also issued a temporary hold on producing affected products.
- After making modifications, Zimmer Holdings resumed producing Trilogy products without metallic spikes, which now meet FDA requirements.
- According to a report by Reuters, the plant was located in Ponce, Puerto Rico.
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