Recall Z-1963-2019— Zimmer Biomet, Inc.

Name: FDA recall Z-1963-2019
Creator: U.S. Food and Drug Administration
Published: 2019-06-04

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2019-06-04, terminated 2021-07-21. It names one FDA 510(k) clearance: K031280. Product: Ultra-Drive Irrigation Tubing Assembly, Reference Number 423834 - Product Usage: Item used with the UltraDrive System to provide proper irrigation during the cutting and removal of bone and acrylic bone cement in orthopedic applications.. Reason: The products do not have sufficient data to support the labeled shelf life of 10 years..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-06-04
Terminated: 2021-07-21
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K031280 — ULTRA-DRIVE 3Biomet, Inc.·cleared 2003-09-22

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

Ultra-Drive Irrigation Tubing Assembly, Reference Number 423834 - Product Usage: Item used with the UltraDrive System to provide proper irrigation during the cutting and removal of bone and acrylic bone cement in orthopedic applications.

Reason for recall

The products do not have sufficient data to support the labeled shelf life of 10 years.

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