Exactech recalls specific hip prosthesis components due to incorrect size labeling on packaging. Affected units have serial numbers 6465589-6465618 and 6465641. No immediate action needed as the hazard is a labeling error.
Biolox Delta Femoral Head was packaged and labeled as 170-36-00 (36mm +0), but the device was marked as 170-36-03 (36mm +3.5).
Exactech is recalling certain hip prosthesis components because they were labeled with the wrong size (36mm +3.5 instead of 36mm +0). This labeling error means the device might not fit properly in surgery, but no injuries have been reported.
The recalled femoral head was labeled as 36mm +3.5 instead of the correct 36mm +0. This size difference could lead to improper fitting during hip replacement surgery, potentially causing complications if the component doesn't match the patient's anatomy.
Patients who received hip replacements using the recalled Exactech BIOLOX Delta Femoral Head components (serial numbers 6465589-6465618 and 6465641) are most at risk. Surgeons and medical facilities that used these components during surgery are also affected.
Check if your hip prosthesis has the serial numbers 6465589-6465618 or 6465641. The product was labeled as 170-36-00 but marked as 170-36-03 in the packaging.
Check the serial numbers on your hip prosthesis component. If they match 6465589-6465618 or 6465641, this unit is affected.
The product was recalled because it was labeled with the wrong size (170-36-03 instead of 170-36-00), which could lead to improper fitting during hip replacement surgery.
The recall is due to a labeling error, not an immediate safety hazard. No injuries have been reported, and the risk is low if the component is used correctly.
Check the serial numbers on your hip prosthesis component. Affected units have serial numbers 6465589-6465618 or 6465641.
We’ve drafted a message you can send Exactech to request your refund or repair — edit it as you like.
Subject: Recall Z-2250-2021 — Exactech Exactech Hello, I own a Exactech that is covered by recall Z-2250-2021 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.
