Innomed, Inc. is recalling 41 units of the Innomed Cup Removal Starter Instrument (REF 520054), a tool used during hip replacement surgeries. The recall was initiated because a 54 MM finisher blade was incorrectly attached to the instrument's handle instead of the required 54 MM starter blade. This manufacturing error affects devices from Lot Number 1223K and could lead to surgical complications if the wrong blade type is used during a procedure.
The use of a finisher blade when a starter blade is required may cause the instrument to perform incorrectly during surgery, potentially leading to bone damage, improper implant removal, or extended surgical time. No specific injuries have been reported to date, but the mismatch creates a risk of surgical error.
Manufacturer contact and correction
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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