FDA Recall
Terminated
INBONE Total Ankle System, INBONE POLY INSERT SZ 2+ 14mm SULCUS
Recall: Z-0316-2022
·
Initiated November 4, 2021
Recall
- Recall Number
- Z-0316-2022
- Event Number
- 89007
- Firm
- Wright Medical Technology Inc
- FEI Number
- 1043534
- Product Code
- HSN
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- November 4, 2021
- Terminated
- January 6, 2023
- Address
- 11576 Memphis Arlington Rd, Arlington, TN, 38002-9497
Description
INBONE Total Ankle System, INBONE POLY INSERT SZ 2+ 14mm SULCUS
Reason
The package contents and package labeling do not match.
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.
Distribution
US Nationwide distribution in the states of MI and PA.
Quantity
2 units