FDA recall Z-1924-2020

Product

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

US Nationwide distribution.

Key facts

Status

Terminated

Initiation date

2020-04-09

Report date

2020-05-13

Termination date

2020-11-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Arlington, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1924-2020