Recall Z-1266-2015— Zimmer, Inc.

Name: FDA recall Z-1266-2015
Creator: U.S. Food and Drug Administration
Published: 2015-01-28

Class II · Terminated

Class II FDA medical device recall by Zimmer, Inc., initiated 2015-01-28, terminated 2018-03-13. It names one FDA 510(k) clearance: K121771. Product: Persona Trabecular Metal Tibial Plate / Persona TM Tibia-Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer For use in either posterior cruciate retaining or sacrificing surgical procedures.. Reason: An increase in complaints of loosening and radiolucent lines..

Recalling firm: Zimmer, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-01-28
Terminated: 2018-03-13
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 Tibial Plate / Persona TM Tibia-Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer For use in either posterior cruciate retaining or sacrificing surgical procedures.

Reason for recall

An increase in complaints of loosening and radiolucent lines.

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