Synovo recalls femoral resurfacing cups (model numbers 01-03-0042 to 01-03-0052) that were marketed without FDA clearance. Consumers should contact the manufacturer for details.
Medical device components were marketed without FDA clearance
Synovo is recalling certain femoral resurfacing cups that were sold without FDA clearance. This means the devices may not meet safety standards and could pose health risks if used in medical procedures.
Medical devices must be cleared by the FDA before being used in surgeries. These cups were marketed without this clearance, meaning they might not be safe for use in patients and could lead to complications during hip replacement procedures.
Patients who received these specific femoral resurfacing cups during surgery are likely affected. Medical professionals using the devices for hip replacements may also be at risk.
Check the product's reference numbers: 01-03-0042 to 01-03-0052. These cups have specific model identifiers like 01030044K2NN656 or 01030052L3NN694. They were sold for hip replacement surgeries.
Reach out to Synovo Production directly for specific instructions on how to report the device and get assistance.
The devices were marketed without FDA clearance, which means they may not meet safety standards for medical use.
Check the reference numbers on the device: 01-03-0042 to 01-03-0052, with specific model identifiers like 01030044K2NN656.
Contact Synovo Production directly for instructions on how to report the device and get assistance.
We’ve drafted a message you can send Synovo to request your refund or repair — edit it as you like.
Subject: Recall Z-1498-2024 — Synovo Synovo Hello, I own a Synovo that is covered by recall Z-1498-2024 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.
