GM Helix Acqua Implant 3.5x10, Article No. 140.944
Reported: November 10, 2021 Initiated: October 11, 2021 #Z-0203-2022
Product Description
GM Helix Acqua Implant 3.5x10, Article No. 140.944
Reason for Recall
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.
Details
- Recalling Firm
- Jjgc Industria E Comercio De Materials Dentarios Sa
- Units Affected
- 567 (US)
- Distribution
- US Nationwide distribution.
- Location
- Curitiba, N/A
Frequently Asked Questions
What product was recalled? ▼
GM Helix Acqua Implant 3.5x10, Article No. 140.944. Recalled by Jjgc Industria E Comercio De Materials Dentarios Sa. Units affected: 567 (US).
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 10, 2021. Severity: Moderate. Recall number: Z-0203-2022.
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