GM Helix Acqua Implant 3.5x10, Article No. 140.944
Check against the official notice below — it lists the full affected range.
GM Helix Acqua Implant dental implants with article number 140.944 have been recalled because 3.5x11.5mm implants were mislabeled as 3.5x10mm implants. A total of 567 units were distributed nationwide in the United States under UDI 7899878024897 in lots GNW15 and GRE82. The labeling error poses a risk in certain clinical situations where bone quality is low and the bone ridge height is at its maximum indication for a 10mm implant; if the incorrectly labeled implant is used in these cases, it could result in damage to nerves or adjacent bone structures and cavities.
The source document does not specify a remedy or instructions for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Quantity: 567 (US) Lot/code info: UDI 7899878024897 Lots GNW15 and GRE82
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.