SMART TOE recallZ-1011-2022 · Stryker GmbH · initiated Mar 28, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Stryker GmbH or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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".
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-1011-2022
- Status
- Open, Classified
- Initiated by the company
- Mar 28, 2022
- Recalling firm
- Stryker GmbH
- Quantity
- 246 implants
- Product code
- HTY
- FDA submissions
- K112197
- Distribution
- Worldwide distribution - US Nationwide and the countries including Australia, Canada, Chile, China, France, Germany, Netherlands, New Zealand, Spain, Sweden, Switzerland, and United Kingdom.
Product description
Smart Toe II Intramedullary Arthrodesis Implant
Code information (models, lots, serial numbers)
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)
Devices named in this recall
5 devices in the FDA device registry whose identifier appears in the recall's code information.
- SMART TOE ST0A-16PStryker GmbH · PIN, FIXATION, SMOOTH1 recall5 reports
- SMART TOE ST0-19PStryker GmbH · PIN, FIXATION, SMOOTH1 recall2 reports
- SMART TOE ST0-22PStryker GmbH · PIN, FIXATION, SMOOTH1 recall0 reports
- SMART TOE ST0XS-11Stryker GmbH · PIN, FIXATION, SMOOTH1 recall0 reports
- SMART TOE ST0XS-13Stryker GmbH · PIN, FIXATION, SMOOTH1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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