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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-2300-2014
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
Tibial Articular Surface Provisional Bottom
Nonsterile
PSN A/S PROV L CD BOTTOM +0MM
PSN A/S PROV L CD BOTTOM +6MM
PSN A/S PROV L EF BOTTOM +0MM
PSN A/S PROV L EF BOTTOM +6MM
PSN A/S PROV L GH BOTTOM +0MM
PSN A/S PROV L GH BOTTOM +6MM
PSN A/S PROV L J BOTTOM +0MM
PSN A/S PROV L J BOTTOM +6MM
PSN A/S PROV R CD BOTTOM +0MM
PSN A/S PROV R CD BOTTOM +6MM
PSN A/S PROV R EF BOTTOM +0MM
PSN A/S PROV R EF BOTTOM +6MM
PSN A/S PROV R GH BOTTOM +0MM
PSN A/S PROV R GH BOTTOM +6MM
PSN A/S PROV R J BOTTOM +0MM
PSN A/S PROV R J BOTTOM +6MM
Code Information Item Numbers: 42517600303, 42517600313, 42517600505, 42517600515, 42517600707, 42517600717, 42517600909, 42517600919, 42527600303, 42527600313, 42527600505, 42527600515, 42527600707, 42527600717, 42527600909, 42527600919    Lot Numbers:  62345370 62402721 62423922 62424796 62494665 62563912 62590524 62696878 62717331 62347233 62399612 62428432 62505575 62563917 62592279 62692687 62352330 62416376 62432157 62490790 62563913 62590525 62696881 62357329 62374803 62412999 62432797 62490792 62563911 62654931 62717334 62357328 62372411 62407772 62432794 62463961 62525489 62563914 62575756 62702758 62724743 62358632 62373739 62405896 62432154 62463962 62563916 62656074 62710626 62432790 62462267 62572574 62443455 62456923 62568289 62357865 62410790 62423921 62424804 62500930 62573363 62695299 62347240 62399870 62430403 62504858 62572571 62692683 62732165 62357866 62406970 62432150 62479624 62573364 62695293 62351310 62410788 62435708 62507548 62569955 62698727 62358633 62373740 62410789 62432796 62465722 62517280 62581856 62695873 62363685 62364505 62407568 62432152 62463963 62505999 62572570 62695889 62710608 62432792 62499171 62704629 62445747 62497257 
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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