Health product recall

WB Anatomic Healing Abutment XC

Last updated

Summary

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

Affected products

Affected products

Lot or serial number

Model or catalog number

WB Anatomic Healing Abutment XC

All 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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Dental
Companies

Institut Straumann Ag

Peter Merian-Weg 12, Basel, Switzerland, 4002

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-77322

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