| Class 2 Device Recall Persona TASP |  |
Date Initiated by Firm | June 10, 2013 |
Date Posted | August 21, 2014 |
Recall Status1 |
Terminated 3 on September 11, 2014 |
Recall Number | Z-2299-2014 |
Recall Event ID |
68817 |
510(K)Number | K113369 |
Product Classification |
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
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Product | Persona (TM) The Personalized Knee System
UC Tibial Articular Surface Provisional Top
Nonsterile
TASP UC L 3-7 CD TOP
TASP UC L 4-11 EF TOP
TASP UC L 7-12 GH TOP
TASP UC L 9-12 J TOP |
Code Information |
Item Numbers: 42517200410 42517200510 42517200610 42517200710 Lot Numbers: 62034570 62117742 62156315 62187322 62247350 62314721 62372409 62381836 62397160 62429190 62474906 62551390 62565048 62595853 62614781 62700416 62702297 62724349 62043548 62055681 62104368 62117743 62144794 62165545 62177246 62256282 62351288 62356244 62391228 62427419 62456268 62506003 62551338 62564355 62597762 62614786 62702292 62705808 62717332 62055682 62068376 62068378 62144795 62152727 62187323 62256283 62351289 62386419 62356275 62445931 62456266 62558584 62575757 62611087 62638672 62698749 62330130 62563854 62567418 |
Recalling Firm/ Manufacturer |
Zimmer, Inc. 1800 W Center St Warsaw IN 46580-2304
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = JWH
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