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Class 2 Device Recall Persona TASP PS |
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| Date Initiated by Firm |
June 10, 2013 |
| Date Posted |
August 21, 2014 |
| Recall Status1 |
Terminated 3 on September 11, 2014 |
| Recall Number |
Z-2296-2014 |
| Recall Event ID |
68817 |
| 510(K)Number |
K113369
|
| Product Classification |
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
|
| Product |
Persona (TM) The Personalized Knee System
PS Tibial Articular Surface Provisional Top
Nonsterile
TASP PS L 3-5 CD TOP
TASP PS L 3-5 CD TOP
TASP PS L 3-5 CD TOP
TASP PS L 3-5 CD TOP
TASP PS L 3-5 CD TOP
TASP PS L 3-5 CD TOP
TASP PS L 3-5 CD TOP
TASP PS L 3-5 CD TOP
TASP PS L 3-5 CD TOP
TASP PS L 3-5 CD TOP
TASP PS L 3-5 CD TOP
TASP PS L 3-5 CD TOP
TASP PS L 3-5 CD TOP
TASP PS L 3-5 CD TOP
TASP PS L 3-5 CD TOP
TASP PS L 3-5 CD TOP
TASP PS L 3-5 CD TOP
TASP PS L 3-5 CD TOP
TASP PS L 3-5 CD TOP
TASP PS L 6-9 CD TOP
TASP PS L 6-9 CD TOP
TASP PS L 6-9 CD TOP
TASP PS L 6-9 CD TOP
TASP PS L 6-9 CD TOP
TASP PS L 6-9 CD TOP
TASP PS L 6-9 CD TOP
TASP PS L 6-9 CD TOP
TASP PS L 6-9 CD TOP
TASP PS L 6-9 CD TOP
TASP PS L 6-9 CD TOP
TASP PS L 6-9 CD TOP
TASP PS L 6-9 CD TOP
TASP PS L 6-9 CD TOP
TASP PS L 6-9 CD TOP
TASP PS L 6-9 CD TOP
TASP PS L 6-9 CD TOP
TASP PS L 6-9 CD TOP
TASP PS L 6-9 CD TOP
TASP PS L 6-9 CD TOP
TASP PS L 6-9 CD TOP
TASP PS L 6-9 CD TOP
TASP PS L 3-5 EF TOP
TASP PS L 3-5 EF TOP
TASP PS L 3-5 EF TOP
TASP PS L 3-5 EF TOP
TASP PS L 3-5 EF TOP
TASP PS L 3-5 EF TOP
TASP PS L 3-5 EF TOP
TASP PS L 3-5 EF TOP
TASP PS L 3-5 EF TOP
TASP PS L 3-5 EF TOP
TASP PS L 3-5 EF TOP
TASP PS L 3-5 EF TOP
TASP PS L 3-5 EF TOP
TASP PS L 3-5 EF TOP
TASP PS L 3-5 EF TOP
TASP PS L 3-5 EF TOP
TASP PS L 3-5 EF TOP
TASP PS L 3-5 EF TOP
TASP PS L 3-5 EF TOP
TASP PS L 3-5 EF TOP
TASP PS L 3-5 EF TOP
TASP PS L 3-5 EF TOP
TASP PS L 3-5 EF TOP
TASP PS L 3-5 EF TOP
TASP PS L 6-9 EF TOP
TASP PS L 6-9 EF TOP
TASP PS L 6-9 EF TOP
TASP PS L 6-9 EF TOP
TASP PS L 6-9 EF TOP
TASP PS L 6-9 EF TOP
TASP PS L 6-9 EF TOP
TASP PS L 6-9 EF TOP
TASP PS L 6-9 EF TOP
TASP PS L 6-9 EF TOP
TASP PS L 6-9 EF TOP
TASP PS L 6-9 EF TOP
TASP PS L 6-9 EF TOP
TASP PS L 6-9 EF TOP
TASP PS L 6-9 EF TOP
TASP PS L 6-9 EF TOP
TASP PS L 6-9 EF TOP
TASP PS L 6-9 EF TOP
TASP PS L 6-9 EF TOP
TASP PS L 10-11 EF TOP
TASP PS L 10-11 EF TOP
TASP PS L 10-11 EF TOP
TASP PS L 10-11 EF TOP
TASP PS L 10-11 EF TOP
TASP PS L 10-11 EF TOP
TASP PS L 10-11 EF TOP
TASP PS L 10-11 EF TOP
TASP PS L 10-11 EF TOP
TASP PS L 10-11 EF TOP
TASP PS L 10-11 EF TOP
TASP PS L 10-11 EF TOP
TASP PS L 10-11 EF TOP
TASP PS L 10-11 EF TOP
TASP PS L 10-11 EF TOP
TASP PS L 10-11 EF TOP
TASP PS L 10-11 EF TOP
TASP PS L 6-9 GH TOP
TASP PS L 6-9 GH TOP
TASP PS L 6-9 GH TOP
TASP PS L 6-9 GH TOP
TASP PS L 6-9 GH TOP
TASP PS L 6-9 GH TOP
TASP PS L 6-9 GH TOP
TASP PS L 6-9 GH TOP
TASP PS L 6-9 GH TOP
TASP PS L 6-9 GH TOP
TASP PS L 6-9 GH TOP
TASP PS L 6-9 GH TOP
TASP PS L 6-9 GH TOP
TASP PS L 6-9 GH TOP
TASP PS L 6-9 GH TOP
TASP PS L 6-9 GH TOP
TASP PS L 6-9 GH TOP
TASP PS L 6-9 GH TOP
TASP PS L 10-12 GH TOP
TASP PS L 10-12 GH TOP
TASP PS L 10-12 GH TOP
TASP PS L 10-12 GH TOP
TASP PS L 10-12 GH TOP
TASP PS L 10-12 GH TOP
TASP PS L 10-12 GH TOP
TASP PS L 10-12 GH TOP
TASP PS L 10-12 GH TOP
TASP PS L 10-12 GH TOP
TASP PS L 10-12 GH TOP
TASP PS L 10-12 GH TOP
TASP PS L 10-12 GH TOP
TASP PS L 10-12 GH TOP
TASP PS L 10-12 GH TOP
TASP PS L 10-12 GH TOP
TASP PS L 10-12 GH TOP
TASP PS L 10-12 GH TOP
TASP PS L 10-12 GH TOP
TASP PS L 10-12 GH TOP
TASP PS L 10-12 GH TOP
TASP PS L 10-12 J TOP
TASP PS L 10-12 J TOP
TASP PS L 10-12 J TOP
TASP PS L 10-12 J TOP
TASP PS L 10-12 J TOP
TASP PS L 10-12 J TOP
TASP PS L 10-12 J TOP
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| Code Information |
Item Numbers: 42517400410 42517400510 42517400610 42517400710 42517400810 42517400910 42517401010 Lot Numbers: 62043556 62110045 62121489 62125589 62147235 62168383 62177247 62165546 62311021 62314722 62386421 62442838 62525491 62558585 62605208 62627292 62683432 62696865 62717343 62022344 62041351 62073566 62104372 62117744 62121488 62149175 62187324 62187325 62247351 62311022 62314723 62364961 62391117 62436468 62474903 62538403 62564311 62611089 62669905 62690895 62720225 62020946 62028233 62073570 62110047 62130976 62187327 62187329 62189325 62290822 62305407 62314724 62386424 62420258 62469459 62531662 62565041 62551356 62584447 62612266 62687089 62690049 62690909 62702763 62724739 62022345 62024978 62104374 62124040 62134006 62200223 62200224 62233921 62294595 62314725 62385328 62436479 62511942 62544381 62565042 62597795 62669933 62696869 62710618 62043559 62104415 62121530 62203396 62203397 62314728 62314730 62356529 62390841 62442847 62511926 62565057 62551396 62595859 62654933 62656069 62720226 62034569 62055683 62113088 62130978 62149714 62165547 62168384 62177253 62184260 62256285 62256284 62397161 62420223 62511956 62565108 62551402 62601570 62696376 62043561 62055684 62116593 62152728 62145793 62166196 62166195 62168385 62184261 62239294 62319851 62320878 62356546 62390865 62474905 62538415 62565044 62581863 62622558 62632819 62740693 62398035 62440437 62515479 62515499 62563803 62581853 62675491 |
Recalling Firm/
Manufacturer |
Zimmer, Inc.
1800 W Center St
Warsaw IN 46580-2304
|
| For Additional Information Contact |
800-613-6131
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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 and Original Applicant = ZIMMER INC.
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