Persona (TM) The Personalized Knee System PS Tibial Articular Surface Provisional Top Nonsterile TASP PS L 3-5 CD TOP TA

FDA device recall Z-2296-2014 · posted 2014-08-21 · Terminated

Recall details

Recalling firm

Zimmer, Inc.

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.

Action taken

On February 10, 2014, Zimmer sent letter to surgeons who had filed complaints regarding the affected TASP fractures. The letter provided the surgeons with Zimmer's investigational findings of the issue. Surgeons were directed to send questions or any additional informtion to Zimmer.PER@Zimmer.com. The Zimmer Weekly Wrap-Up, dated February 14, 2014, was issued electronically to sales force. They were notified to engage in mandatory training to improve the usage of the TASPs and prevent potential breakage. Zimmer has taken additional corrective measures by initiating another recall in July 2014 whereby they notify the distributors as well as all users of the enhanced surgical technique.

Root cause

Device Design

Status

Terminated

Product code

JWH

Quantity affected

70,986 distribution events

Distribution

Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, N

Date initiated

2013-06-10

Date posted

2014-08-21

Date terminated

2014-09-11

Location

Warsaw, IN

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