Z-1924-2020 Class II Terminated
FDA device recall Z-1924-2020 was initiated by Wright Medical Technology Inc on April 9, 2020 and is designated Class II. Reason for recall: One lot of INBONE Tibial Trays is missing the plasma coating. The recall status is terminated (terminated November 2, 2020). Affected quantity: 22 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 13, 2020
- Initiation Date
- April 9, 2020
- Termination Date
- November 2, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 22 units
Product 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 for Recall
One lot of INBONE Tibial Trays is missing the plasma coating.
Distribution Pattern
US Nationwide distribution.
Code Information
Lot code 1619947