GM Helix Acqua Implant 3.5x10, Article No. 140.944
Summary
The FDA issued a Class II for GM Helix Acqua Implant 3.5x10, Article No. 140.944 by Jjgc Industria E Comercio De Materials Dentarios Sa. Reason: 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 indicatio.
Details
Source
Device Recall
External ID
Z-0203-2022
Action Date
2021-11-10
Status
Terminated
Category
device
Product Description
GM Helix Acqua Implant 3.5x10, Article No. 140.944
Lot/Code Info: UDI 7899878024897 Lots GNW15 and GRE82
Quantity Affected: 567 (US)
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.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-10-11
Company
Curitiba, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 120 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Jjgc Industria E Comercio De Materials Dentarios Sa) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Jjgc Industria E Comercio De Materials Dentarios Sa have FDA actions?
This is the only FDA action we have on record for Jjgc Industria E Comercio De Materials Dentarios Sa in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0203-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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