PERSONA" The Personalized Knee System UC Tibial Articular Surface Provisional Left Size 3-7 CD Top; Left Size 4-11 EF Top; Left Size 7-12 GH Top; Left Size 9-12 J Top; Right Size 3-7 CD Top; Right Size 4-11 EF Top; Right Size 7-12 GH Top; and Right Size 9-12 J Top.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Part Numbers: 42517200410, 42517200510, 42517200610, 42517200710, 42527200410, 42527200510, 42527200610, and 42527200710. Lot numbers:62034570, 62117742, 62156315, 62187322, 62247350, 62314721, 62372409, 62381836, 62397160, 62429190, 62474906, 62551390, 62565048, 62595853, 62614781, 62700416, 62702297, 62724349, 62043548, 62055681, 62104368, 62117743, 62144794, 62165545, 62177246, 62256282, 62351288, 62356244, 62391228, 62427419, 62456268, 62506003, 62551338, 62564355, 62597762, 62614786, 62702292, 62705808, 62717332, 62055682, 62068376, 62068378, 62144795, 62152727, 62187323, 62256283, 62351289, 62356275, 62386419, 62445931, 62456266, 62558584, 62575757, 62611087, 62638672, 62698749, 62736074, 62736075, 62330130, 62563854, 62567418, 62622596, 62070845, 62102088, 62130979, 62149717, 62200303, 62240485, 62256293, 62351304, 62356605, 62391239, 62420238, 62469444, 62551099, 62581081, 62597792, 62627223, 62696849, 62715617, 62059519, 62072593, 62103263, 62110051, 62196614, 62198205, 62248171, 62351307, 62385105, 62401423, 62468266, 62558588, 62595866, 62690052, 62715613, 62072225, 62103266, 62144798, 62156319, 62209049, 62229728, 62282887, 62315140, 62356622, 62386430, 62401427, 62427062, 62428459, 62505998, 62565073, 62581864, 62627283, 62690948, 62696884, 62717330, 62398030, 62428342, 62444343, 62510048, 62515508, 62516058, and 62600154.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
ā ļø Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Zimmer, Inc.
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
PERSONA" The Personalized Knee System UC Tibial Articular Surface Provisional Left Size 3-7 CD Top; Left Size 4-11 EF Top; Left Size 7-12 GH Top; Left Size 9-12 J Top; Right Size 3-7 CD Top; Right Size 4-11 EF Top; Right Size 7-12 GH Top; and Right Size 9-12 J Top.
Product Codes/Lot Numbers:
Part Numbers: 42517200410, 42517200510, 42517200610, 42517200710, 42527200410, 42527200510, 42527200610, and 42527200710. Lot numbers:62034570, 62117742, 62156315, 62187322, 62247350, 62314721, 62372409, 62381836, 62397160, 62429190, 62474906, 62551390, 62565048, 62595853, 62614781, 62700416, 62702297, 62724349, 62043548, 62055681, 62104368, 62117743, 62144794, 62165545, 62177246, 62256282, 62351288, 62356244, 62391228, 62427419, 62456268, 62506003, 62551338, 62564355, 62597762, 62614786, 62702292, 62705808, 62717332, 62055682, 62068376, 62068378, 62144795, 62152727, 62187323, 62256283, 62351289, 62356275, 62386419, 62445931, 62456266, 62558584, 62575757, 62611087, 62638672, 62698749, 62736074, 62736075, 62330130, 62563854, 62567418, 62622596, 62070845, 62102088, 62130979, 62149717, 62200303, 62240485, 62256293, 62351304, 62356605, 62391239, 62420238, 62469444, 62551099, 62581081, 62597792, 62627223, 62696849, 62715617, 62059519, 62072593, 62103263, 62110051, 62196614, 62198205, 62248171, 62351307, 62385105, 62401423, 62468266, 62558588, 62595866, 62690052, 62715613, 62072225, 62103266, 62144798, 62156319, 62209049, 62229728, 62282887, 62315140, 62356622, 62386430, 62401427, 62427062, 62428459, 62505998, 62565073, 62581864, 62627283, 62690948, 62696884, 62717330, 62398030, 62428342, 62444343, 62510048, 62515508, 62516058, and 62600154.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2580-2014
Related Recalls
Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-EĀæ Bearing due to a commingle. The outer package is labeled as a Size F 44 mm, however, the implant inside the package is a Size G 46 mm, and vice versa.
Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-EĀæ Bearing due to a commingle. The outer package is labeled as a Size F 44 mm, however, the implant inside the package is a Size G 46 mm, and vice versa.
The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems.