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Smart toe ii intramedullary arthrodesis implant
Official notice
11 Apr 2022
Last checked
11 Apr 2022
An official Health Canada notice concerns Smart toe ii intramedullary arthrodesis implant. 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 Published 2022-04-11.
What to do now
Contact the manufacturer if you require additional information.
Recall number
64070
Official notice
2022-04-11
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the VIN on your vehicle against the official list. If your VIN is listed, follow the official notice.
Recall Numbers
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Turn on automatic VIN checksAffected products
Affected products
Product 1
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected vehicles were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand
Manufacturer
Phone
Brand: Stryker, Smart.
Source & status
Source & status
Source
Tier
Category
Classification
App estimate
Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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