Health product recall

Smart Toe II Intramedullary Arthrodesis Implant

Brand(s)
Last updated

Summary

Product
Smart Toe II Intramedullary Arthrodesis Implant
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected Products Lot or Serial Number Model or catalog number
Smart Toe Ii Intramedullary Arthrodesis Implant H54191, H56502, H54193 ST0-19P, ST0A-16P, ST0-22P

Issue

Stryker has identified a potential nonconformance for five lots of Smart Toe II implants (three of which have been imported into Canada). Specifically, the nickel-sensitivity statement on the outer carton may be partially covered by a label resulting in the statement showing "indicated for patients with nickel sensitivity" instead of "not indicated for patients with nickel sensitivity". The issue is detectable. The contraindications are clearly stated and visible in the instructions for use (IFU).

Recall start date: Mar 30, 2022

Additional information

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

Stryker Gmbh

Bohnackerweg 1, Selzach, Solothurn

Switzerland, 2545

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-64070