Exactech recalls AcuMatch L-Series 22mm Bipolar Hip Liners produced between 2004 and August 2021 that lacked the specified EVOH layer in packaging. This could lead to improper hip joint function during surgery.
The AcuMatch L-Series 22mm Inner Diameter Bipolar Hip Liner lots were packaged without the specified ethylene vinyl alcohol (EVOH) layer. Between 2004 and August 2021, our packaging process utilized two different types of packaging materials: 1) Low Density Polyethylene (LDPE), Nylon, and EVOH, or 2) LDPE and Nylon without EVOH.
Exactech is recalling certain AcuMatch L-Series 22mm Bipolar Hip Liners that were packaged without the required EVOH layer between 2004 and August 2021. This defect could cause improper hip joint function during surgery if used without the correct packaging.
The recalled hip liners were packaged without the ethylene vinyl alcohol (EVOH) layer that is critical for proper surgical function. This missing layer could lead to improper hip joint alignment during hip replacement surgery, potentially causing complications.
Patients who received hip replacements using these specific AcuMatch L-Series 22mm Bipolar Hip Liners between 2004 and August 2021 are most at risk. Surgeons and medical facilities that used these items during that time period may also be affected.
Check if your hip liner has item numbers 100-22-19 to 100-22-25 with specific lot numbers listed in the recall notice. These were produced between 2004 and August 2021.
Review the item numbers and lot numbers listed in the recall notice to confirm if your hip liner is affected.
The AcuMatch L-Series 22mm Hip Liners were packaged without the specified EVOH layer between 2004 and August 2021, which could lead to improper hip joint function during surgery.
The recall notice does not specify a remedy, so you should check the product details against the list of affected item numbers and lot numbers provided in the recall notice.
The recall states that the missing EVOH layer could lead to improper hip joint function during surgery, but no specific injury risks are described.
We’ve drafted a message you can send Exactech to request your refund or repair — edit it as you like.
Subject: Recall Z-2236-2024 — Exactech Exactech Hello, I own a Exactech that is covered by recall Z-2236-2024 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.
