Exactech is recalling various hip, knee, shoulder, and ankle replacement systems after reports that the inner vacuum bags used for packaging have lost their seal. This defect can affect the integrity of the device before it is used in surgery. The recall follows three complaints involving four specific devices where the vacuum seal was compromised.
A loss of vacuum in the inner packaging bag may expose the orthopedic implants to environmental conditions that could potentially compromise the device's performance or sterility. While no injuries have been explicitly detailed in this report, the company has received multiple complaints regarding this specific packaging failure.
Healthcare provider notification and return of product
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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