—#129088

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

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: 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

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 #129088. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.