GM Helix Implant, Endosseous Dental Implant Article No. 109.984
Straumann USA LLC
The hazard
There may be a mismatch between the implant contained inside the packaging and the information described on the outer carton label. If the the incorrect implant is installed, the issue could cause bone compression or difficulty during installation in situations where there is sufficient bone volume FDA Class II recall.
The remedy
Follow FDA guidance
About this recall
GM Helix Implant, Endosseous Dental Implant Article No. 109.984
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model UDI-DI 7899878024552 Lot MVXJ9UPC 7899878024552Would you have heard about this one?
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