INBONE Total Ankle System, INBONE POLY INSERT SZ 2 10mm SULCUS
FDA Recall Z-0315-2022 · Posted None
Recalling FirmWright Medical Technology Inc
Recall StatusTerminated
Product CodeHSN
Date Initiated2021-11-04
Date Terminated2023-01-06
Product Quantity0 (2 Quarantined)
Reason for Recall
The package contents and package labeling do not match.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
US Nationwide distribution in the states of MI and PA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.