Recall Z-2301-2014— Zimmer, Inc.

Name: FDA recall Z-2301-2014
Creator: U.S. Food and Drug Administration
Published: 2013-06-10

Class II · Terminated

Class II FDA medical device recall by Zimmer, Inc., initiated 2013-06-10, terminated 2014-09-11. It names one FDA 510(k) clearance: K123459. Product: Persona (TM) The Personalized Knee System CPS Tibial Articular Surface Provisional Top Nonsterile TASP MLC L 3-5 CD TOP TASP MLC L 6-9 CD TOP TASP MLC L 3-5 EF TOP TASP MLC L 6-9 EF TOP TASP MLC L 10-11 EF TOP TASP MLC L 6-9 GH TOP. Reason: Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). This is a retrospective recall which covers Zimmer's corrective actions taken earlier this year concerning the TASPs..

Recalling firm: Zimmer, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-06-10
Terminated: 2014-09-11
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K123459 — ZIMMER PERSONA TM PERSONALIZED KNEE SYSTEMZimmer, Inc.·cleared 2013-02-22

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

Persona (TM) The Personalized Knee System CPS Tibial Articular Surface Provisional Top Nonsterile TASP MLC L 3-5 CD TOP TASP MLC L 6-9 CD TOP TASP MLC L 3-5 EF TOP TASP MLC L 6-9 EF TOP TASP MLC L 10-11 EF TOP TASP MLC L 6-9 GH TOP

Reason for recall

Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). This is a retrospective recall which covers Zimmer's corrective actions taken earlier this year concerning the TASPs.

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