FDASeptember 1, 2024device
Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Dental implant box incorrectly labels the diameter as 4,5 X 18,0 mm, but the internal label correctly labels the diameter as 4,0 X 18,0 mm; if the dentist drills the bone with the larger diameter stated on the box, the smaller diameter implant, will become loose and will not fit, which may necessitate an additional surgery.
What to do
FDA enforcement status: Ongoing
Brands named
sin sistema de implante nacionalsinsin sistema
UPCs
07899995273437
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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