Exactech recalls specific hip prosthesis components due to incorrect labeling that could lead to improper fit. Affected units have serial numbers 6465619-6465640 and 6465642-6465648.
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 replacement femoral heads that were labeled incorrectly. This could cause improper fit during surgery if used with the wrong size component.
The recalled femoral heads were labeled as 170-36-00 (36mm +0) but were actually marked as 170-36-03 (36mm +3.5). This labeling error could lead to using the wrong size component during hip replacement surgery, potentially causing improper fit.
Patients who received hip replacements using the recalled Exactech BIOLOX Delta Femoral Head components (serial numbers 6465619-6465640 and 6465642-6465648) are affected. Surgeons and medical facilities that used these components during procedures are most at risk.
Check if your hip prosthesis has the serial numbers 6465619-6465640 or 6465642-6465648. The product was labeled as 170-36-03 but marketed as 170-36-00.
Identify if your hip prosthesis has serial numbers 6465619-6465640 or 6465642-6465648.
The recall was issued because the femoral heads were labeled incorrectly as 170-36-00 but were actually 170-36-03, which could lead to improper fit during hip replacement surgery.
The correct size is 36mm +3.5mm (170-36-03), but the product was labeled as 36mm +0 (170-36-00).
Check the serial numbers on your hip prosthesis; affected units have serial numbers 6465619-6465640 or 6465642-6465648.
We’ve drafted a message you can send Exactech to request your refund or repair — edit it as you like.
Subject: Recall Z-2251-2021 — Exactech Exactech Hello, I own a Exactech that is covered by recall Z-2251-2021 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
