Lower riskMedical device recall · FDA · Published October 11, 2021
GM Helix Acqua Implant 3.5x10 Mislabeling Risk: Nerve Damage Possible
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.
Take action
Contact the company
📍Recalling firmJjgc Industria E Comercio De Materials Dentarios SaAv Juscelino Kubitschek De Oliveira · Curitiba, Brazil
“GM Helix Acqua Implant 3.5x10 Mislabeling Risk: Nerve Damage Possible.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61698-gm-helix-acqua-implant-3-5x10-mislabeling-risk-nerve-damage. Based on FDA recall #Z-0203-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0203-2022%22&limit=1).
The Food and Drug Administration announced on Oct. 11, 2021, that Jjgc Industria E Comercio De Materials Dentarios Sa is recalling GM Helix Acqua Implant 3.5x10 units because they were mislabeled as 3.5x11.5mm implants. The agency said the error could result in damage to nerves or adjacent bone structures if installed. Owners should contact the company for a remedy.
The recall involves 3.5x11.5mm implants mislabeled as 3.5x10mm implants. The FDA said that in borderline cases where bone quality is low and the ridge has a maximum indication for implant height of 10mm, installing the incorrect implant could result in damage to the nerve or adjacent bone structures/cavities.
Context
GovInfoNow's records show Jjgc Industria E Comercio De Materials Dentarios Sa has 1 other recall on record since Dec. 23, 2019. Other recent recalls of similar products include Neodent Tapered Guided Surgery Drill Recall: Incorrect Laser Engraving Label (Dec. 23, 2019), Straumann GM Helix Dental Implant Recall: Packaging Mismatch Risk (July 13, 2026) and Straumann GM Helix Implant Recall: Packaging vs. Actual Dimensions Mismatch (Aug. 12, 2026). XTANT Medical Xpress Pedicle Screw System: Incorrect Labeling Risk was also recalled on Feb. 18, 2026.
How to tell if you have this one
Check for UDI 7899878024897 and lots GNW15 or GRE82 on the implant packaging. The product is sold under the brand Jjgc Industria.
Brand
Jjgc Industria
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Implant Details
Look for UDI 7899878024897 and lots GNW15 or GRE82 on the implant packaging.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.3 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-0203-2022 (October 11, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0203-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.