FDA Recall
Terminated
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.
Recall: Z-1924-2020
·
Initiated April 9, 2020
Recall
- Recall Number
- Z-1924-2020
- Event Number
- 85439
- Firm
- Wright Medical Technology Inc
- FEI Number
- 1043534
- Product Code
- HSN
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- April 9, 2020
- Terminated
- November 2, 2020
- Address
- 11576 Memphis Arlington Rd, Arlington, TN, 38002-9497
Description
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.
Reason
One lot of INBONE Tibial Trays is missing the plasma coating.
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.
Distribution
US Nationwide distribution.
Quantity
22 units