Stryker GmbH: Medical Device Recall in 2022 - (Recall #: Z-1011-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Smart Toe II Intramedullary Arthrodesis Implant

Product Classification:

Class II

Date Initiated: March 28, 2022

Date Posted: May 4, 2022

Recall Number: Z-1011-2022

Event ID: 89861

Reason for Recall:

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".

Status: Ongoing

Product Quantity: 246 implants

Code Information:

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)

Distribution Pattern:

Worldwide distribution - US Nationwide and the countries including Australia, Canada, Chile, China, France, Germany, Netherlands, New Zealand, Spain, Sweden, Switzerland, and United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated