Health Products

WB Anatomic Healing Abutment XC

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Dental
Product: WB Anatomic Healing Abutment XC
Issue: Medical devices - Labelling and packaging
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalog number
WB Anatomic Healing Abutment XCAll lots.064.4522S
064.4523S

Issue

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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