GM Helix Acqua Implant 3.5x10, Article No. 140.944
Hazard
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 You Should Do
The firm initially contacted affected customers by phone on October 11, 2021. Customers were instructed to immediately stop using the product and to place all impacted product in quarantine. The firm then followed up with a confirmation letter sent by UPS on October 22, 2021. Customers were instructed to identify and segregate the affected units, open or closed, in their stock. Product is to be returned to the manufacturer.' If product has been installed and the patient reports an issue (such as numbness, pain, or other symptoms), please notify the distributor immediately to receive instructions on how to proceed.
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Products
- Brand
- Jjgc Industria E Comercio De Materials Dentarios Sa Av Juscelino Kubitschek De Oliveira Curitiba Brazil
- UPC
- UDI 7899878024897 Lots GNW15 and GRE82
Units Affected
567 (US)