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Stryker GmbH recalls Smart Toe II Intramedullary Arthrodesis Implant
Recalled May 4, 2022 · FDA recall Z-1011-2022 · Stryker
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". · FDA Class II
Units
246 implants
Sold at
Worldwide distribution - US Nationwide and the countries including Australia, Canada, Chile, China, France, Germany, Netherlands, New Zealand, Spain, Sweden, Switzerland, and United Kingdom.
Description
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".
Product
Smart Toe II Intramedullary Arthrodesis Implant
Manufacturer(s)
Stryker GmbH
Made in
Switzerland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →