FDA Device

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

Hazard

The package contents and package labeling do not match.

What You Should Do

Remedy

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.

Products

INBONE Total Ankle System, INBONE POLY INSERT SZ 2 10mm SULCUS
Brand
Wright Medical Technology Inc
UPC
Model 220222210E, Lot Code 05113580751661825 (GTIN: 00840420124968)

Units Affected

0 (2 Quarantined)