GM Helix Ac: 3.5x10 implants mislabeled as 3.5x10mm. Low bone quality may cause nerve damage if incorrect size installed. Affected units: UDI 7899878024897, Lots GNW15 and GRE82.
3.5x11.5mm implants were mislabeled as 3.5x10mm implants. In borderline cases where the bone quality is low and the bone ridge has a maximum indication for the implant height (10mm), if the incorrect implant is installed, it could result in damage to the nerve or adjacent bone structures/cavities.
GM Helix Acqua Implant 3.5x10 units were mislabeled as 3.5x10mm. In cases with low bone quality, using the wrong size could damage nerves or bone. This recall affects dental implants sold in specific batches.
The implants were mislabeled as 3.5x10mm when they are actually 3.5x11.5mm. In patients with low bone quality, using the larger implant could cause nerve damage or bone structure issues.
Dental patients who received the GM Helix Acqua Implant 3.5x10 (Article No. 140.944) with UDI 7899878024897 from lots GNW15 and GRE82. Patients with low bone quality are at slightly higher risk.
Check for UDI 7899878024897 and lots GNW15 or GRE82 on the implant packaging. The product is sold under the brand Jjgc Industria.
Look for UDI 7899878024897 and lots GNW15 or GRE82 on the implant packaging.
In patients with low bone quality, using the 3.5x11.5mm implant (labeled as 3.5x10mm) could cause nerve damage or bone structure issues.
Check for UDI 7899878024897 and lots GNW15 or GRE82 on the implant packaging.
The recall record does not specify a remedy.
We’ve drafted a message you can send Jjgc Industria to request your refund or repair — edit it as you like.
Subject: Recall Z-0203-2022 — Jjgc Industria Jjgc Industria Hello, I own a Jjgc Industria that is covered by recall Z-0203-2022 from Jjgc Industria. 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.
