Z-2105-2023Class II

Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile

Name: Z-2105-2023 Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile
Creator: Wright Medical Technology, Inc.
Published: 2023-06-13
License: https://open.fda.gov/license/

Wright Medical Technology Inc / initiated 2023-06-13 / Open, Classified / root cause: manufacturing process

FDA source

Wright Medical Technology, Inc. began a recall of Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile on 2023-06-13. FDA classified it as Class II and gives the reason as "The devices were manufactured with the pin sleeve holes too narrow, which does not allow the pin sleeves to pass through the pin sleeve holes, thereby preventing pin placement through the pin holes". 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-2105-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-06-13
Posted: 2023-07-07
Recalling firm: Wright Medical Technology Inc
Product: Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile.
Product code: HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Reason for recall: The devices were manufactured with the pin sleeve holes too narrow, which does not allow the pin sleeves to pass through the pin sleeve holes, thereby preventing pin placement through the pin holes.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm issued a Field Safety Correction Action (FSCA) Medical Devices Vigilance System form to the lead competent authority, ANSM-France, via email on 6/13/2023 for their review and approval for the recall to be carried out in their jurisdiction. The FSCA identified the affected product, a description of the issue, and advice on actions to be taken by the distributor and the user. The advice included to check the inventory to locate the product listed and remove and isolate/quarantine it to prevent accidental use. A business reply form was to be returned by email to confirm receipt of the notification and document product segregation. Upon receipt of the reply form, Stryker will contact the consignee for return of the product. If the devices have been distributed to other organizations, contact details are requested so that Stryker can inform the recipients appropriately. If the consignee is a distributor, they are responsible for notifying their affected customers. An undated recall letter accompanied the FSCA that will be issued once the lead competent authority approves it. The content of the letter was similar to the FSCA and contained a business reply form.
Quantity in commerce: 106 devices
Distribution: There was no U.S. distribution, including government and military. Foreign distribution was made to Australia, Belgium, Canada, Chile, China, Colombia, France, Germany, Italy, Mexico, Netherlands, Spain, Sweden, Switzerland, Taiwan, and the United Kingdom.
Product codes and lots: Lot numbers 2656815 and 2762126, UDI-DI 00889797003926.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2105-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2105-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-12	2023-07-06

Product code HSN

K123954Class IIInfinity Total Ankle SystemWrightmedicaltechnologyinc / cleared 2013-04-01

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)