FDA recall Z-1257-2022

Product

DJO EMPOWR 3D Knee (Right) 10mm Tibial Insert, REF: 342-10-708

Reason for recall

A right, size 8, knee tibial insert package may include a mispackaged, left ,size 4, knee tibial insert. If implanted, a risk may include leaving debris in the joint space.

Distribution

U.S. Nationwide distribution in the states of TN, MN, IL, IN, SC, MS, CA, KS.

Key facts

Status

Ongoing

Initiation date

2022-05-05

Report date

2022-06-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Austin, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1257-2022