Synovo Production recalls acetabular bearing medical devices sold without FDA clearance. Check reference numbers for affected items.
Medical device components were marketed without FDA clearance
Synovo Production is recalling acetabular bearings that were marketed without FDA clearance. This could pose a risk to patients using these components in joint replacements.
Medical devices must be cleared by the FDA before being sold. These bearings were sold without this clearance, which could lead to safety issues if used in joint replacements.
Patients using acetabular bearings for joint replacements may be affected. Those with the specific reference numbers listed are most at risk.
Check for reference numbers like 01-02-4254, 01-02-4456, or 01-02-4558 on the product packaging. The product is an acetabular bearing used in joint replacements.
Look for reference numbers on the product packaging to determine if it is affected.
The product was marketed without FDA clearance, which is a regulatory requirement for medical devices.
Check the reference numbers listed in the recall notice, such as 01-02-4254 or 01-02-4456.
The recall notice does not specify a remedy, so contact the manufacturer for further instructions.
We’ve drafted a message you can send Synovo Production to request your refund or repair — edit it as you like.
Subject: Recall Z-1497-2024 — Synovo Production Synovo Production Hello, I own a Synovo Production that is covered by recall Z-1497-2024 from Synovo Production. 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.
