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PERSONA The Personalized Knee System Constrained Tibial… recallZ-2575-2014 · Zimmer, Inc. · initiated Aug 7, 2014

Class II Terminated All recalls posted in September 2014

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Zimmer, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Device Design

What the company is doing

On 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.

Recall details

Recall number
Z-2575-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Aug 7, 2014
Posted by the FDA
Sep 4, 2014
Recalling firm
Zimmer, Inc.
Quantity
77,737 units total
Product code
JWH
FDA submissions
K113369, K123459
Distribution
Worldwide 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.

Product description

PERSONA The Personalized Knee System Constrained Tibial Articular Surface Provisional BOTTOM with the following: L CD +0MM; L CD +6MM; L EF +0MM;L EF +6MM; L GH +0MM; L GH +6MM; L J +0MM; L J +6MM; R CD +0MM; R CD +6MM; R EF +0MM; R EF +6MM; R GH +0MM; R GH +6MM; R J +0MM; R J +6MM; and

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

Part Numbers: 42517600303, 42517600313, 42517600505, 42517600515, 42517600707, 42517600717, 42517600909, 42517600919, 42527600303, 42527600313, 42527600505, 42527600515, 42527600707, 42527600717, 42527600909, and 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, and 62497257.

Other devices under the same FDA submission

316 devices cleared under K113369, K123459 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 68878).

Sources and updates

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