Recall Z-0884-2021— Exactech, Inc.

Name: FDA recall Z-0884-2021
Creator: U.S. Food and Drug Administration
Published: 2020-11-09

Class II · Ongoing

Class II FDA medical device recall by Exactech, Inc., initiated 2020-11-09. It names one FDA 510(k) clearance: K042021. Product: Equinoxe Humeral Stem, Primary, Press Fit, 11mm. Reason: Potential for incorrect Instructions For Use (IFU) included with an Equinoxe Humeral Stem, Primary, Press Fit, 11mm package..

Recalling firm: Exactech, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2020-11-09
Firm location: Gainesville, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K042021 — EXACTECH EQUINOXE SHOULDER SYSTEMExactech, Inc.·cleared 2004-10-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Equinoxe Humeral Stem, Primary, Press Fit, 11mm

Reason for recall

Potential for incorrect Instructions For Use (IFU) included with an Equinoxe Humeral Stem, Primary, Press Fit, 11mm package.

Data sourced from openFDA. This site is unofficial and independent of the FDA.