Recall Z-0315-2022 ยท HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Wright Medical Technology Inc
INBONE Total Ankle System, INBONE POLY INSERT SZ 2 10mm SULCUS
| Date | Nov 4, 2021 |
| Status | Terminated |
| Reason | The package contents and package labeling do not match. |
| 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 | 0 (2 Quarantined) |
| Distribution | US Nationwide distribution in the states of MI and PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100886 | INBONE II TOTAL ANKLE REPLACEMENT Wrightmedicaltechnologyinc, Aug 26, 2010 |