Incipio Devices is recalling 100 units of the Offset Cup Impactor (3/8-16 interface), which is a reusable surgical instrument used by doctors to position and place hip implants during surgery. The recall was issued because the TIG weld on the instrument may fracture, meaning the tool does not meet manufacturing specifications. While incidents of these fractures have been reported, specific injury counts have not been provided.
A fracture of the tool's weld during a surgical procedure could cause the instrument to fail, potentially leading to the improper placement of a hip implant or causing unexpected delays while the patient is in surgery.
Used to position and place acetabular sup implants. Recall Number: Z-0549-2025.
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.
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Sources: FDA iRES · Raw API Response
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