GM Helix Acqua Implant 3.5x10 recall: Labeling Error
GM Helix Acqua Implant 3.5x10, Article No. 140.944
Why was GM Helix Acqua Implant 3.5x10 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI 7899878024897 Lots GNW15 and GRE82
- Product
- GM Helix Acqua Implant 3.5x10, Article No. 140.944
- Recalling firm
- Jjgc Industria E Comercio De Materials Dentarios Sa
- Quantity
- 567 (US)
- Distribution
- US Nationwide distribution.
- Recall date
- November 10, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)