Stryker GmbH Recall 89861
Description: Smart Toe II Intramedullary Arthrodesis Implant
Stryker GmbH Recall 89861 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1011-2022 |
| Event ID | 89861 |
| Event Description | Smart Toe II Intramedullary Arthrodesis Implant |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide and the countries including Australia, Canada, Chile, China, France, Germany, Netherlands, New Zealand, Spain, Sweden, Switzerland, and United Kingdom. |
| Quantity | 246 implants |
| Recall Reason | 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". |
| Device Classification | 20220504 |
| Device 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) |
| Center Classification Date | 20220427 |
| Recall Initiation Date | 20220328 |
| Recalling Firm | Stryker GmbH |
| Initial Notification | Letter |
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