Health product recall

Tandem INTL Bipolar 46OD 28ID

Last updated

Summary

Product
Tandem INTL Bipolar 46OD 28ID
Issue
Medical devices - Performance
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

Tandem INTL Bipolar 46OD 28ID

W2401399

71324046

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

Additional information

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

Smith & Nephew, Inc.

1450 Brooks Road, Memphis, Tennessee, United States, 38116

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-76411

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