Reported Nov 10, 2021 · Terminated
GM Helix Acqua Implant 3.5x10, Article No. 140.944
Jjgc Industria E Comercio De Materials Dentarios Sa
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Jjgc Industria E Comercio De Materials Dentarios Sa · Av Juscelino Kubitschek De Oliveira · Curitiba, N/A · N/A
Is this the product you have?
GM Helix Acqua Implant 3.5x10Article No. 140.944
- Lot codes and dates
- UDI 7899878024897 Lots GNW15 and GRE82
- Amount recalled
- 567 (US)
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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