Device product
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
Z-2575-2014
Product summary
- Firm
- Zimmer, Inc.
- Event
- Event 68878
- Status
- Terminated
- Classification
- Class II
- Quantity
- 77,737 units total
- Official record key
device-enforcement:Z-2575-2014
Official wording
Reason: 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.
Code information: 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.
Distribution pattern: 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.
Derived failure modes
-
Unknown
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.