Smart Toe II Intramedullary Arthrodesis Implant
Brand(s)
Summary
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
Stryker Gmbh
Bohnackerweg 1, Selzach, Solothurn
Switzerland, 2545
Get notified
Receive notifications for new and updated recalls and alerts by category.