PERSONA The Personalized Knee System CR Tibial recall
PERSONA The Personalized Knee System CR Tibial Articular Surface Provisional with the following: Left Size 3-9 CD Top; Left Size 3-11 EF Top; Left…
Why was PERSONA The Personalized Knee System CR Tibial 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Part Numbers: 42517000410, 42517000510, 42517000610, 42517000710, 42527000410, 42527000510, 42527000610, and 42527000710. Lot numbers: 62024975, 62043546, 62144792, 62152725, 62165538, 62187318, 62337961, 62372407, 62386776, 62397159, 62405917, 62456263, 62499170, 62551386, 62565051, 62568272, 62572572, 62663168, 62691384, 62707494, 62717346, 62020920, 62144793, 62156313, 62165539, 62184228, 62353932, 62356176, 62385100, 62420242, 62468277, 62538412, 62564340, 62611088, 62612263, 62690056, 62702295, 62717337, 62736078, 62024976, 62054776, 62147232, 62177243, 62187319, 62187320, 62359057, 62364955, 62391222, 62414006, 62461233, 62558583, 62564345, 62608889, 62638657, 62646286, 62702749, 62724348, 62394279, 62443397, 62487490, 62492802, 62506001, 62563915, 62568271, 62704633, 62055686, 62144796, 62161537, 62162597, 62256286, 62351297, 62356578, 62385099, 62404282, 62424802, 62455897, 62538392, 62565037, 62595855, 62611083, 62663162, 62680121, 62686205, 62695286, 62724347, 62724744, 62019863, 62156317, 62165548, 62168386, 62184268, 62256288, 62344258, 62356586, 62391232, 62391233, 62455892, 62504877, 62551337, 62564335, 62597816, 62638685, 62646284, 62695878, 62036673, 62138318, 62149715, 62189326, 62189327, 62356593, 62377738, 62391236, 62420225, 62461232, 62564360, 62564361, 62595865, 62611086, 62680120, 62690951, 62710615, 62761109, 62394280, 62428338, 62444959, 62500931, and 62568278.
- Product
- PERSONA The Personalized Knee System CR Tibial Articular Surface Provisional with the following: Left Size 3-9 CD Top; Left Size 3-11 EF Top; Left…
- Recalling firm
- Zimmer, Inc.
- Quantity
- 77,737 total units
- 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.
- Recall date
- September 10, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)