Class 2 Device Recall Persona TASP

• Date Initiated by Firm: June 10, 2013
• Date Posted: August 21, 2014
• Recall Status: Terminated on September 11, 2014
• Recall Number: Z-2301-2014
• Recall Event ID: 68817
• 510(K)Number: K123459
• Product Classification: Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
• 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
• Code Information: Item Numbers: 42517600410 42517600510 42517600610 42517600710 42517600810 42517600910 Lot Numbers: 62342526 62423918 62423919 62423920 62427414 62482212 62563745 62612225 62656072 62740698 62342527 62405895 62430401 62504179 62511925 62563784 62638665 62695870 62343066 62406967 62432146 62515486 62564324 62691390 62717335 62351291 62374838 62415307 62430397 62518138 62622527 62696875 62357867 62374796 62427836 62441229 62511924 62565948 62563908 62590523 62695295 62361315 62376662 62420192 62434748 62518137 62540059 62563778 62627131 62698733
• Recalling Firm/ Manufacturer: Zimmer, Inc.; 1800 W Center St; Warsaw IN 46580-2304
• For Additional Information Contact: 800-613-6131
• Manufacturer 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.
• FDA Determined Cause: Device Design
• Action: 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.
• Quantity in Commerce: 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, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WY, and the countries of Australia, Canada, Germany, India, Japan, Korea, and Singapore.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = JWH