Recall Z-0696-2021— Zimmer Biomet, Inc.

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2020-11-20, terminated 2022-05-26. FDA's recall record names no specific 510(k) clearance for this event. Product: Spinal Rod Cutter, Item number 00392500200. The product is a nonsterile pin cutter - Product Usage: The intended use of this instrument is to be used for cutting orthopedic rods/pins during orthopedic surgeries.. Reason: Device has the potential for fracture during use..

Recalling firm
Zimmer Biomet, Inc.
Classification
Class II
Status
Terminated
Initiated
2020-11-20
Terminated
2022-05-26
Firm location
Warsaw, IN, United States

Product description

Spinal Rod Cutter, Item number 00392500200. The product is a nonsterile pin cutter - Product Usage: The intended use of this instrument is to be used for cutting orthopedic rods/pins during orthopedic surgeries.

Reason for recall

Device has the potential for fracture during use.

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