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
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