Exactech recalls specific shoulder implants due to incorrect label translations that may cause confusion about product size. Affected units include certain right humeral stems with 10.5mm 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 specific shoulder implants that have labels with incorrect translations. This could lead to confusion about the implant's size, potentially causing improper use or fitting.
The labels on the implants contain the word 'long' in all languages except English. Since the implants are standard length fracture stems, this translation error could cause confusion about the implant's size during use or fitting.
Individuals who purchased or use the Exactech Equinoxe shoulder implant with the specific model and size (10.5mm right humeral stem) are affected. Surgeons and patients using this implant are most at risk of confusion.
Check for the Exactech Equinoxe shoulder implant with the model number REF 304-22-11 and size 10.5mm right humeral stem. The product was sold through OUS distribution channels.
Review the label for the word 'long' in the language of your label. If it's not English, this implant may be affected.
Exactech identified incorrect translations on the labels for certain implants, which could cause confusion about the implant's size.
Check the label translation for the word 'long' in your language. If it's not English, contact Exactech for guidance.
The recall is for translation errors that could cause confusion, not a direct risk of injury. The danger level is low risk.
We’ve drafted a message you can send Exactech to request your refund or repair — edit it as you like.
Subject: Recall Z-0873-2020 — Exactech Exactech Hello, I own a Exactech that is covered by recall Z-0873-2020 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.
