Z-1291-2022Class II

Stryker INFINITY Resect Guide for INBONE Talus, Size 4, Model #33620254, non-sterile, an instrument used with...

Name: Z-1291-2022 Stryker INFINITY Resect Guide for INBONE Talus, Size 4, Model #33620254, non-sterile, an instrument used with...
Creator: Wright Medical Technology, Inc.
Published: 2022-06-02
License: https://open.fda.gov/license/

Wright Medical Technology Inc / initiated 2022-06-02 / Open, Classified / root cause: manufacturing process

FDA source

Wright Medical Technology, Inc. began a recall of Stryker INFINITY Resect Guide for INBONE Talus, Size 4, Model #33620254, non-sterile, an instrument used with the INFINITY Total Ankle System on 2022-06-02. FDA classified it as Class II and gives the reason as "The instrument is incorrectly color coded". 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-1291-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-06-02
Posted: 2022-06-27
Recalling firm: Wright Medical Technology Inc
Product: Stryker INFINITY Resect Guide for INBONE Talus, Size 4, Model #33620254, non-sterile, an instrument used with the INFINITY Total Ankle System.
Product code: HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Reason for recall: The instrument is incorrectly color coded.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The recalling firm issued letters dated 2-June-2022 via email. The letter was issued to the distributors but the noticed was flagged to the attention of health care professionals, operators of medical devices, and distributors. The letter provided the product description, issue, potential risks, and actions needed as follows: (1) Immediately check the inventory to locate the product listed on the attached business reply form and remove it from its point of use; (2) Return the enclosed business reply form by email to confirm receipt of this notification and document product segregation; (3) Upon receipt of the completed business reply form, Stryker will contact the consignee to arrange for the return and replacement of the product; (4) Maintain awareness of this communication internally until all required actions have been completed within the consignee facility; (5) If the product has been further distributed, notify all affected parties at once about the recall. A copy of this notification can be used to send to the consignees. If possible, the recalling firm should be informed if any of the devices have been further distributed, including contact details, so that the recalling firm can inform the recipients appropriately. If the consignee first receiving the letter is a distributor, they are responsible for notifying their affected customers.
Quantity in commerce: 35 units
Distribution: Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IA, IL, MA, MI, MN, MO, NC, NY, OH, PA, TX, and WA. The countries of Australia, Belgium, Canada, France, Germany, Hong Kong, Israel, Sweden, Switzerland, and United Kingdom.
Product codes and lots: Lot #2039558, GTIN 00889797006552.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1291-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1291-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-07-06	2022-06-27

Product code HSN

K140749Class IIInfinity Total Ankle SystemWrightmedicaltechnologyinc / cleared 2014-04-25

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)