Recall Z-3176-2018— Zimmer Biomet, Inc.

Name: FDA recall Z-3176-2018
Creator: U.S. Food and Drug Administration
Published: 2018-07-20

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2018-07-20, terminated 2020-06-04. It names one FDA 510(k) clearance: K982497. Product: Gentle Thread PLGA Round Head Interference Screw, 7x20mm, Item Number 905612. Reason: The Gentle Thread PLGA Round Head, 7x20mm and the Gentle Thread PLGA Full Thread 10x30 have been commingled..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-07-20
Terminated: 2020-06-04
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K982497 — ARTHROTEK INTERFERENCE SCREWBiomet, Inc.·cleared 1998-10-16

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

Gentle Thread PLGA Round Head Interference Screw, 7x20mm, Item Number 905612

Reason for recall

The Gentle Thread PLGA Round Head, 7x20mm and the Gentle Thread PLGA Full Thread 10x30 have been commingled.

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