Recall Z-1917-2016— Zimmer Biomet, Inc.

Name: FDA recall Z-1917-2016
Creator: U.S. Food and Drug Administration
Published: 2016-05-11

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2016-05-11, terminated 2017-06-02. It names one FDA 510(k) clearance: K121771. Product: Persona Trabecular Metal Tibia; Persona Trabecular Metal Tibial Plate Instruments and Modular Brackets; Used to facilitate the implantation of joint replacement implants.. Reason: Zimmer Inc. is initiating a recall of specific Persona" Trabecular Metal" Tibial Plate Instruments and Modular Brackets, due to incidents of radiolucent lines and loosening in implants..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-05-11
Terminated: 2017-06-02
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K121771 — ZIMMER PERSONA THE PERSONALIZED KNEE SYSTEMZimmer, Inc.·cleared 2012-11-07

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

Persona Trabecular Metal Tibia; Persona Trabecular Metal Tibial Plate Instruments and Modular Brackets; Used to facilitate the implantation of joint replacement implants.

Reason for recall

Zimmer Inc. is initiating a recall of specific Persona" Trabecular Metal" Tibial Plate Instruments and Modular Brackets, due to incidents of radiolucent lines and loosening in implants.

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