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Health Canada Medical devices

Tandem INTL Bipolar 46OD 28ID

Issued October 30, 2024
Issue
Smith & Nephew, Inc., has initiated a field action to voluntarily remove a batch of Tandem Bipolar 46OD 28ID due to the assembly of an oversized retainer ring in the product. This results in a reduced retention force of the bipolar assembly. Recall Start Date: October 15, 2024
Hazard description
Performance
Product
Product name
Tandem INTL Bipolar 46OD 28ID
Reference
ID
RA-76411