Exactech recalls specific shoulder implants due to incorrect label translations that may cause confusion about product size. Affected units include right humeral stems with 6.5mm size.
Labels with incorrect translations were identified by Exactech is a distributor in the Netherlands. The translations on the outer labels include the word " long" in all languages other than the original English version. The implants are standard length fracture stems.
Exactech is recalling certain shoulder implants because labels have incorrect translations that say 'long' in languages other than English. This could lead to confusion about the implant's size, but it does not pose a direct safety risk.
The labels on the implants incorrectly translate the word 'long' in all languages except English. This could cause confusion about the implant's actual size, but the implants themselves are standard length and not dangerous in normal use.
Patients who received the specific Exactech Equinoxe shoulder implant (right humeral stem, 6.5mm, REF 304-22-07) from OUS distribution are affected. Surgeons and patients using this implant are most at risk of confusion.
Check for the Exactech Equinoxe shoulder implant with a right humeral stem, 6.5mm size, and reference number 304-22-07. These were distributed through OUS channels.
Look for labels that say 'long' in languages other than English, which may indicate the recalled implant.
Exactech identified incorrect translations on labels that say 'long' in all languages except English, which could cause confusion about the implant's size.
No, the implants are standard length and not dangerous in normal use. The recall is for potential confusion about size, not safety risks.
Check for the Exactech Equinoxe shoulder implant with a right humeral stem, 6.5mm size, and reference number 304-22-07, which were distributed through OUS channels.
We’ve drafted a message you can send Exactech to request your refund or repair — edit it as you like.
Subject: Recall Z-0872-2020 — Exactech Exactech Hello, I own a Exactech that is covered by recall Z-0872-2020 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.
