Exactech is a leading medical device manufacturer specializing in orthopedic, cardiovascular, and surgical implants. They provide innovative solutions for various medical procedures.
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).
Exactech is a leading medical device manufacturer with a focus on orthopedic, cardiovascular, and surgical implants. Their products are used in various medical procedures to improve patient outcomes.
Low risk of harm due to rigorous quality control and regulatory compliance
Patients, healthcare providers, and medical facilities
Check for proper labeling, certification, and compliance with medical device regulations
Ensure the device is labeled with the correct manufacturer information and model number
Verify that the device has the appropriate regulatory certifications (e.g., FDA, CE)
Consult with a healthcare professional before use
Yes, Exactech is a well-established and reputable medical device manufacturer with a strong track record in the industry.
Exactech produces a wide range of medical devices, including orthopedic implants, cardiovascular devices, and surgical instruments.
Exactech devices undergo rigorous quality control and regulatory compliance checks to ensure safety and effectiveness.
We’ve drafted a message you can send Exactech to request your refund or repair — edit it as you like.
Subject: Recall Z-1404-2024 — Exactech Exactech Hello, I own a Exactech that is covered by recall Z-1404-2024 from Exactech. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
