Smart Toe II Intramedullary Arthrodesis Implant recall
Smart Toe II Intramedullary Arthrodesis Implant
Why was Smart Toe II Intramedullary Arthrodesis Implant recalled?
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".
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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)
- Product
- Smart Toe II Intramedullary Arthrodesis Implant
- Recalling firm
- Stryker GmbH
- Quantity
- 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.
- Recall date
- May 4, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)