FDA-Device2022-05-04Class II
Smart Toe II Intramedullary Arthrodesis Implant
Stryker GmbH
Hazard
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".
Sold states
Worldwide distribution - US Nationwide and the countries including Australia, Canada, Chile, China, France, Germany, Netherlands, New Zealand, Spain, Sweden, Switzerland, and United Kingdom.
Affected count
246 implants
Manufactured in
Bohnackerweg 1, Selzach, Switzerland
Products
Smart Toe II Intramedullary Arthrodesis Implant
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1011-2022Don't want to check this manually?
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