Health Canada — Medical Devices · Canada · 2025-04-23 · Type II
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Reported risk: Institut Straumann Ag received a complaint from a customer that the blister label for the WB XL Anatomic Healing Abutments says "RB/WB" instead of "WB", where "RB" and "WB" refer to the compatibility with the prosthetic connection (regular base and wide base). While the label on the outer box is correct, due to the incorrect blister label the use of the mislabeled WB abutments on RB implants cannot be excluded, in which case the abutment connection would exceed the implant shoulder. The affected devices were distributed from 2025-01-30 to 2025-03-13. Recall Start Date: April 7, 2025
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