Recall Z-0603-2018— Exactech, Inc.

Name: FDA recall Z-0603-2018
Creator: U.S. Food and Drug Administration
Published: 2017-07-11

Class II · Terminated

Class II FDA medical device recall by Exactech, Inc., initiated 2017-07-11, terminated 2021-04-22. It names one FDA 510(k) clearance: K162567. Product: Exactech GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical tool. Reason: Vix Bit may fracture during use..

Recalling firm: Exactech, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-07-11
Terminated: 2021-04-22
Firm location: Gainesville, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K162567 — ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho·cleared 2017-04-05

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

Exactech GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical tool

Reason for recall

Vix Bit may fracture during use.

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