—#129087

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

FDA product code: JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K123459
Affected lot / code info: 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

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Zimmer, Inc.
Address: 1800 W Center St, Warsaw, Indiana 46580-2304

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2013-06-10
Posted by FDA: 2014-08-21
Terminated: 2014-09-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #129087. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.