Device recall: BIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 3.4MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured

FDA's record gives the reason for recall as: "A limited number of product pouches may not have been sealed during packaging."

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

FDA's distribution pattern field reads: "Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden"

FDA lists the status as Terminated; the termination date is 26 Jul 2019. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.