Z-0315-2022Class II

INBONE Total Ankle System, INBONE POLY INSERT SZ 2 10mm SULCUS

Name: Z-0315-2022 INBONE Total Ankle System, INBONE POLY INSERT SZ 2 10mm SULCUS
Creator: Wright Medical Technology Inc
Published: 2021-11-04
License: https://open.fda.gov/license/

Wright Medical Technology Inc / initiated 2021-11-04 / Terminated / root cause: manufacturing process

FDA source

Wright Medical Technology Inc began a recall of INBONE Total Ankle System, INBONE POLY INSERT SZ 2 10mm SULCUS on 2021-11-04. FDA classified it as Class II and gives the reason as "The package contents and package labeling do not match". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0315-2022
Classification: Class II
Status: Terminated
Initiated: 2021-11-04
Posted: 2021-12-01
Terminated: 2023-01-06
Recalling firm: Wright Medical Technology Inc
Product: INBONE Total Ankle System, INBONE POLY INSERT SZ 2 10mm SULCUS
Product code: HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Reason for recall: The package contents and package labeling do not match.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Affected consignees were notified via email and/or Federal Express mail. Consignees are asked to immediately quarantine all recalled products on hand and return all affected product to Wright Medical Arlington TN Warehouse as soon as possible. If the consignee has further distributed the affected product, they are asked to notify the applicable parties at once about this recall. The consignee may copy and distribute the notification letter and Wright Medical will work directly with them to collect the recalled items.
Quantity in commerce: 0 (2 Quarantined)
Distribution: US Nationwide distribution in the states of MI and PA.
Product codes and lots: Model 220222210E, Lot Code 05113580751661825 (GTIN: 00840420124968)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0315-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0315-2022	Class II	Terminated	Voluntary: Firm initiated	2021-12-08	2021-12-01
Z-0316-2022	Class II	Terminated	Voluntary: Firm initiated	2021-12-08	2021-12-01

Product code HSN

K100886Class IIInbone II Total Ankle ReplacementWrightmedicaltechnologyinc / cleared 2010-08-26

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)