Exactech recalls specific hip implants due to incorrect labeling. Affected models include Alteon HA Femoral Stem, Size 5. This may cause confusion in surgical use. Contact Exactech for details.
Wrong device description of the label identifying the implant
Exactech is recalling certain hip implants (Alteon HA Femoral Stem, Size 5) because the device label description is incorrect. This could lead to confusion during surgery, potentially affecting the correct implant selection.
The label on the implant incorrectly describes the device, which could cause confusion during surgery. This might lead to the wrong implant being used, potentially affecting the surgical outcome.
Patients who received the specific Exactech hip implants with serial numbers listed in the recall are affected. Surgeons and medical professionals using these implants during hip replacement procedures are at higher risk.
Check if your hip implant has the model name 'Alteon HA Femoral Stem, Press-Fit, Extended Offset, Cementless, HA Coated, Collared, Size 5'. Look for the listed serial numbers in the recall notice.
Verify if your hip implant matches the model and serial numbers listed in the recall notice.
The recalled model is Exactech Alteon HA Femoral Stem, Press-Fit, Extended Offset, Cementless, HA Coated, Collared, Size 5.
The affected serial numbers are 4897288, 4897291, 4897293, 4907465, 4907466, 4907467, 4907469, 4907472, 4907475, 4907476, 4907477, 4907478, 4907479, 4943094, 4943095, 4943096, 4943097, 4943102, 4943104, 4943105, 4943106, 4984977, 4984978, 4984979, 4984980, 4984981, 4984982, 5046901, 5046902, 5046903, 5046904, 5046905, and 5046906.
No immediate action is required. The recall is for label correction, not a safety hazard. Check your implant details and contact Exactech if you have the affected model.
We’ve drafted a message you can send Exactech to request your refund or repair — edit it as you like.
Subject: Recall Z-0538-2018 — Exactech Exactech Hello, I own a Exactech that is covered by recall Z-0538-2018 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.
