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U.S. Department of Health and Human Services

Class 2 Device Recall Persona TASP

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  Class 2 Device Recall Persona TASP see related information
Date Initiated by Firm June 10, 2013
Date Posted August 21, 2014
Recall Status1 Terminated 3 on September 11, 2014
Recall Number Z-2298-2014
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
CR Tibial Articular Surface Provisional Top
Nonsterile

TASP CR L 3-9 CD TOP
Code Information Item Numbers: 42517000410 Lot Numbers:  62024975 62043546 62144792 62152725 62165538 62187318 62337961 62372407 62386776 62397159 62405917 62456263 62499170 62551386 62568272 62572572 62565051 62663168 62691384 62707494 62717346 
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 2		 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 and Original Applicant = ZIMMER INC.
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