Exactech recalls 6.5mm Left Equinoxe Platform Fracture Stems with incorrect laser marking that could lead to improper use in spinal surgery.
The device may be incorrectly laser marked as a right stem, when it should have been laser marked as a left stem.
Exactech is recalling specific 6.5mm left Equinoxe Platform Fracture Stems that may be incorrectly marked as right stems. This could cause improper use during spinal surgery if the wrong stem is installed.
The stem may be laser marked as a right stem instead of left. This could lead to improper installation during spinal surgery, potentially causing complications. However, the hazard is not described as causing serious injury in normal use.
Orthopedic surgeons and medical professionals who use these stems for spinal fusion procedures are most at risk if they install the wrong stem. Patients receiving this specific stem during surgery may be affected.
Check for the model number 304-21-07 and serial numbers between 4968615-4968627 or 4952421-4952432. The product is intended for cemented spinal fusion procedures.
Verify the laser marking on the stem to ensure it is labeled as a left stem.
The stems may be incorrectly laser marked as right stems instead of left stems, which could lead to improper use during spinal surgery.
The affected model is 304-21-07 with serial numbers 4968615-4968627 and 4952421-4952432.
The recall record does not specify a remedy, so no action is required beyond checking the marking.
We’ve drafted a message you can send Exactech to request your refund or repair — edit it as you like.
Subject: Recall Z-0307-2021 — Exactech Exactech Hello, I own a Exactech that is covered by recall Z-0307-2021 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.
