Dental Implants Mislabeled as Smaller Size; Risk of Nerve Damage
GM Helix Acqua Implant dental implants were mislabeled as a smaller size. If incorrectly installed in cases with low bone quality, they could damage the nerve or adjacent bone structures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a medical device with potential for serious harm (nerve and bone damage). No injuries or illnesses have been reported. This fits the rubric criterion for score 3: 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
GM Helix Acqua Implant 3.5x10 dental implants (Article No. 140.944) are being recalled due to a labeling error. The implants were manufactured as 3.5x11.5mm but labeled as 3.5x10mm. This affects 567 units distributed nationwide in the US.
The mislabeling creates a risk of surgical error during implant placement. In cases where bone quality is low or the bone ridge is at maximum height for a 10mm implant, installing the longer 11.5mm implant could damage the inferior alveolar nerve or adjacent bone structures and cavities.
Affected units carry lot numbers GNW15 and GRE82 and can be identified by UDI 7899878024897. The product was manufactured by Jjgc Industria E Comercio De Materials Dentarios Sa.
Patients, dentists, and oral surgeons should verify actual implant dimensions before installation. If you have received one of these implants, contact your healthcare provider immediately to confirm proper sizing and determine whether corrective action is needed.
The recalled product
- Product
- GM Helix Acqua Implant 3.5x10, Article No. 140.944
- Category
- Medical Device — Dental Implant
- Affected units
- 567
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI 7899878024897 Lots GNW15 and GRE82
Distribution
Distributed nationwide across the United States.
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