Recall Z-1310-2021— Arthrex, Inc.

Name: FDA recall Z-1310-2021
Creator: U.S. Food and Drug Administration
Published: 2021-02-24

Class II · Terminated

Class II FDA medical device recall by Arthrex, Inc., initiated 2021-02-24, terminated 2023-05-02. FDA's recall record names no specific 510(k) clearance for this event. Product: Drill Bit, Cannulated, 5.0 mm - Product Usage: may be used in a variety of foot and ankle procedures.. Reason: The color indicator on the proximal end of the shaft of the AR-8770-02 is the incorrect color..

Recalling firm: Arthrex, Inc.
Classification: Class II
Status: Terminated
Initiated: 2021-02-24
Terminated: 2023-05-02
Firm location: Naples, FL, United States

Product description

Drill Bit, Cannulated, 5.0 mm - Product Usage: may be used in a variety of foot and ankle procedures.

Reason for recall

The color indicator on the proximal end of the shaft of the AR-8770-02 is the incorrect color.

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