FDA
Food and Drug Administration · Recall Z-3173-2026 · Aug 12, 2026GM Helix Implant, REF: 109.984;
Straumann USA LLC
The hazard
There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside. FDA Class II recall.
The remedy
Follow FDA guidance
About this recall
GM Helix Implant, REF: 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 REF: 109.984Model UDI: (01)7899878024552(11)251122(17)301121(10)VZPF4Model Lot: VZPF4UPC 7899878024552Would you have heard about this one?
RapidRecall watches everything you own against every new federal recall and emails you the moment something you bought turns up. Free for your most important items.
Start monitoring freeSourced from the Food and Drug Administration’s public recall data. Always verify serial and date ranges against the official notice before acting.