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U.S. Department of Health and Human Services

Class 2 Device Recall Persona

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 Class 2 Device Recall Personasee related information
Date Initiated by FirmAugust 07, 2014
Date PostedSeptember 04, 2014
Recall Status1 Terminated 3 on January 27, 2015
Recall NumberZ-2576-2014
Recall Event ID 68878
510(K)NumberK113369 K123459 
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
ProductPERSONA The Personalized Knee System Constrained Posterior Stabilized Tibial Articular Surface Provisional TOP with the following: L 3-5 CD; L 6-9 CD; L 3-5 EF; L 6-9 EF; L 10-11 EF; L 6-9 GH; L 10-12 GH; L 10-12 J; R 3-5 CD; R 6-9 CD; R 3-5 EF; R 6-9 EF; R 10-11 EF; R 6-9 GH; R 10-12 GH; and R 10-12 J.
Code Information Part Numbers: 42517600410, 42517600510, 42517600610, 42517600710, 42517600810, 42517600910, 42517601010, 42517601110, 42527600410, 42527600510, 42527600610, 42527600710, 42527600810, 42527600910, 42527601010, and 42527601110. 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, 62563908, 62565948, 62590523, 62695295, 62361315, 62376662, 62420192, 62434748, 62518137, 62540059, 62563778, 62627131, 62698733, 62363684, 62367078, 62423914, 62430398, 62494662, 62565936, 62658602, 62695876, 62445930, 62340579, 62344051, 62423923, 62423924, 62423925, 62423926, 62482213, 62563747, 62610937, 62710619, 62342528, 62405897, 62434390, 62515483, 62563726, 62612227, 62695297, 62349892, 62422726, 62434393, 62515488, 62563788, 62631075, 62698741, 62355455, 62374809, 62421505, 62434752, 62522772, 62602612, 62695290, 62717336, 62368460, 62374671, 62415303, 62435709, 62435710, 62435711, 62505567, 62563909, 62565944, 62691386, 62360467, 62374806, 62422729, 62434754, 62504020, 62630275, 62691388, 62698735, 62368463, 62374824, 62423915, 62435712, 62435713, 62499165, 62563927, 62565963, 62446275, and 62502226.
Recalling Firm/
Manufacturer		 Zimmer, Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information Contact
800-613-6131
Manufacturer Reason
for Recall		Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona primary knee surgical technique has been updated. This field action correction is to ensure that all distributors and users of this instrument are aware of the enhanced surgical techniques.
FDA Determined
Cause 2		Device Design
ActionOn 8/7/2014, Zimmer notified all distributors via electronic mail. Distributors that have received affected inventory are also notified via courier. Hospital risk managers and surgeons are also notified via courier. Hospital risk managers and surgeons were provided with a notification identifying the issue and their responsibilities. These responsibilities include ensuring the affected personnel are aware of the contents of the notification. Distributors were sent a notification identifying the issue and to provide a copy of the notification sent to surgeons and risk managers. The distributors will also be instructed as needed to assist with identifying a comprehensive list of surgeons.
Quantity in Commerce77,737 units total
DistributionWorldwide Distribution: US (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY; and countries of: AUSTRALIA, INDIA, JAPAN, KOREA, SINGAPORE, AUSTRIA, BELGIUM, FRANCE, GERMANY, ISRAEL, ITALY, LUXEMBOURG, NETHERLANDS, SAUDI ARABIA, SOUTH AFRICA, SPAIN, SWITZERLAND, UNITED KINGDOM, and UNITED ARAB EMIRATES.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JWH
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