Exactech is a leading manufacturer of medical devices and surgical instruments, specializing in orthopedic, cardiovascular, and neurosurgical products. The company is known for its innovative technology and high-quality products that help improve patient outcomes.
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 manufacturer of medical devices and surgical instruments, specializing in orthopedic, cardiovascular, and neurosurgical products. The company is known for its innovative technology and high-quality products that help improve patient outcomes.
Exactech products are designed to be safe and effective, with rigorous quality control and regulatory compliance. The company adheres to strict standards to ensure patient safety.
All patients who use Exactech medical devices and surgical instruments
Check for the manufacturer's name, product model, and any warnings or instructions on the device packaging or label.
Identify the product model and manufacturer information on the device packaging or label.
Ensure the product is within the expiration date and has not been damaged or tampered with.
Contact Exactech customer support or your healthcare provider if you have concerns about the product's safety or performance.
Exactech is a leading manufacturer of medical devices and surgical instruments, specializing in orthopedic, cardiovascular, and neurosurgical products.
Exactech products undergo rigorous quality control and regulatory compliance checks to ensure safety. Always check the product packaging for expiration dates and ensure the device is not damaged.
Contact Exactech customer support or your healthcare provider for assistance. They can provide guidance on product safety and any necessary actions.
We’ve drafted a message you can send Exactech to request your refund or repair — edit it as you like.
Subject: Recall Z-1412-2024 — Exactech Exactech Hello, I own a Exactech that is covered by recall Z-1412-2024 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.