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U.S. Department of Health and Human Services

Class 2 Device Recall Smart Toe

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  Class 2 Device Recall Smart Toe see related information
Date Initiated by Firm March 28, 2022
Create Date April 27, 2022
Recall Status1 Open3, Classified
Recall Number Z-1011-2022
Recall Event ID 89861
510(K)Number K112197  
Product Classification Pin, fixation, smooth - Product Code HTY
Product Smart Toe II Intramedullary Arthrodesis Implant
Code Information 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)
Recalling Firm/
Manufacturer		 Stryker GmbH
Bohnackerweg 1
Selzach Switzerland
For Additional Information Contact Meghan Wells
901-201.9298
Manufacturer 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".
FDA Determined
Cause 2		 Process control
Action A recall notice was disseminated via mail on 03/28/2022 delivered by FedEx Priority One to Hospital/Medical Facilities and Distributor/Subsidiary via email where inventory records indicate the product was distributed. They are requested to immediately quarantine all recalled products they have and return all affected product to local Stryker GmbH distribution site as soon as possible. If they have further distributed the affected product, they are asked to notify the applicable parties at once about this recall and Stryker will work directly with them to collect the recalled items.
Quantity in Commerce 246 implants
Distribution Worldwide distribution - US Nationwide and the countries including Australia, Canada, Chile, China, France, Germany, Netherlands, New Zealand, Spain, Sweden, Switzerland, and United Kingdom.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = HTY and Original Applicant = MEMOMETAL TECHNOLOGIES
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