Recall Z-1924-2020 ยท HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Wright Medical Technology Inc
WRIGHT INBONE Tibial Tray, Size: 2, Plasma Spray, Left, REF 2000252902 - Product Usage: is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint.
| Date | Apr 9, 2020 |
| Status | Terminated |
| Reason | One lot of INBONE Tibial Trays is missing the plasma coating. |
| Root cause | Nonconforming Material/Component |
| Action | The firm initiated the recall by letter on 04/09/2020. The letter requested the consignee immediately cease use and quarantine the product for return. |
| Quantity | 22 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051023 | TOPEZ TOTAL ANKLE REPLACEMENT Topez Orthopedics, Inc., Nov 15, 2005 |