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Stryker GmbH Recall 89861

Description: Smart Toe II Intramedullary Arthrodesis Implant

Stryker GmbH Recall 89861 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1011-2022
Event ID89861
Event DescriptionSmart Toe II Intramedullary Arthrodesis Implant
Product TypeDevices
DistributionWorldwide distribution - US Nationwide and the countries including Australia, Canada, Chile, China, France, Germany, Netherlands, New Zealand, Spain, Sweden, Switzerland, and United Kingdom.
Quantity246 implants
Recall ReasonThe 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 Classification20220504
Device Code InfoModel 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 Date20220427
Recall Initiation Date20220328
Recalling FirmStryker GmbH
Initial Notification Letter
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