Summary
The FDA issued a Class II for Smart Toe II Intramedullary Arthrodesis Implant by Stryker GmbH. Reason: The nickel-sensitivity statement on the outer carton may be partially covered by a label resulting in the statement showing "Indicated for patients wi.
Details
Source
Device Recall
External ID
Z-1011-2022
Action Date
2022-05-04
Status
Ongoing
Category
device
Product Description
Smart Toe II Intramedullary Arthrodesis Implant
Lot/Code Info: Model Number ST0XS-13; UDI: 07613252263470; Lot Code (Expiration Date): H52262 (08/31/2026) Model Number ST0-19P; UDI: 07613252263340; Lot Code (Expiration Date): H54191 (08/31/2026) Model Number ST0A-16P; UDI: 07613252263418; Lot Code (Expiration Date): H54193 (09/30/2026) Model Number ST0XS-11; UDI: 07613252263456; Lot Code (Expiration Date): H55690 (09/30/2026) Model Number ST0-22P; UDI: 07613252263388; Lot Code (Expiration Date): H56502 (09/30/2026)
Quantity Affected: 246 implants
Reason for Recall
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".
Distribution
Worldwide distribution - US Nationwide and the countries including Australia, Canada, Chile, China, France, Germany, Netherlands, New Zealand, Spain, Sweden, Switzerland, and United Kingdom.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-03-28
Company
Selzach
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 155 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Stryker GmbH has 27 FDA actions in our database, including 10 recalls and 17 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Stryker GmbH) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Stryker GmbH have FDA actions?
Stryker GmbH has 27 FDA actions in our database, including 10 recalls and 17 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1011-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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