Synovo recalls acetabular fixation cups sold without FDA clearance. These medical implants may pose risks if used without proper regulatory approval.
Medical device components were marketed without FDA clearance and without FDA approval
Synovo is recalling acetabular fixation cups that were marketed without FDA clearance. This means the devices might not meet safety standards and could lead to health risks if implanted.
Medical devices must be approved by the FDA before being used in surgeries. These cups were sold without proper clearance, which could mean they don't meet safety standards and might cause complications during or after implantation.
Patients who received these acetabular fixation cups during surgery are likely affected. Surgeons and medical facilities that used the recalled devices are at higher risk.
Check the product's reference numbers: 01-01-0554 through 01-01-0566. Look for UDI/REF numbers like 00814193025807/01-01-0554 or lot numbers such as 01010562H1NN732.
Reach out to your surgeon to discuss whether you received a recalled acetabular fixation cup.
The product was marketed without FDA clearance and approval, which means it may not meet safety standards.
Check the reference numbers listed: 01-01-0554 through 01-01-0566, and look for UDI/REF numbers like 00814193025807/01-01-0554.
Contact your surgeon to determine if you received a recalled cup and discuss next steps.
We’ve drafted a message you can send Synovo to request your refund or repair — edit it as you like.
Subject: Recall Z-1496-2024 — Synovo Synovo Hello, I own a Synovo that is covered by recall Z-1496-2024 from Synovo. 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.
