Stryker GmbH Bohnackerweg 1 Selzach Switzerland Smart Toe II Intramedullary Arthrodesis Implant Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Smart Toe II Intramedullary Arthrodesis Implant
Brand
Stryker GmbH Bohnackerweg 1 Selzach Switzerland
Lot Codes / Batch 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)
Products Sold
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)
Stryker GmbH Bohnackerweg 1 Selzach Switzerland is recalling Smart Toe II Intramedullary Arthrodesis Implant due to The nickel-sensitivity statement on the outer carton may be partially covered by a label resulting in the statement showing "Indicated for patients wi. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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".
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026