Z-1011-2022Class II

Smart Toe II Intramedullary Arthrodesis Implant

Name: Z-1011-2022 Smart Toe II Intramedullary Arthrodesis Implant
Creator: Stryker GmbH
Published: 2022-03-28
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2022-03-28 / Open, Classified / root cause: manufacturing process

FDA source

Stryker GmbH began a recall of Smart Toe II Intramedullary Arthrodesis Implant on 2022-03-28. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1011-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-03-28
Posted: 2022-04-27
Recalling firm: Stryker Corp.
Product: Smart Toe II Intramedullary Arthrodesis Implant
Product code: HTY Pin, Fixation, Smooth
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".
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 246 implants
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 codes and lots: 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)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1011-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1011-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-05-04	2022-04-27

Product code HTY

K112197Class IIMemometal Intra-Medullary Bone FastenerMemometal Technologies / cleared 2011-11-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)