Tibial knee prosthesis recall
Tibial knee prosthesis
Why was Tibial knee prosthesis recalled?
Due to an inconsistency in the raw material process, specific lots may contain units with internal non-homogenous material defects.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
Model: 71420164; 71420166 and 71420184 Lot Numbers: 19MT31457, 19MT31458,19MT31459, 20AT32611, 20AT32612, 20AT32613, 20AT33540, 20AT33541, 20AT33542, 20AT33543, 20AT33544, 20AT33545, 20AT33546, 20AT33547, 20AT33548, 20AT33569, 20AT33570, 20AT33571, 20BT33856, 20BT33857, 20BT33858, 20BT33859, 20BT33860, 20BT33861, 20BT33862, 20BT33863, 20BT33864, 20BT33865, 20BT33866, 20BT33878, 20BT33879, 20BT33880, 20BT33881, 20BT33882, 20BT33883, 20BT33884, 20BT33885, 20BT33886, 20BT33887, 20BT33888, 20BT33889, 20BT34357, 20BT34358, 20BT34359, 20BT34360, 20BT34379, 20BT34380, 20BT34381, 20BT34382, 20BT34383, 20BT34384, 20BT34385, 20BT34386, H2008427, G1923903, G1923904, G1923905, G1923933, G1923934, G1923935, G1923936, G1923964, G1923965, G1923966, G1923967, G1923992, G1923993, G1923994, G1924450, G1924451, G1924452, G1924453, G1924480, G1924481, G1924482, G1924483, G1924512, G1924513, G1924514, G1924543, G1924544, G1924545, G1924571, G1924572, G1924573, G1925072, G1925073, G1925074, G1925075, G1925102, G1925106, G1925107, G1925108, G1925109, G1925137, G1925138, G1925139, G1925140, G1925165, G1925166, G1925167, G1925168, G1925194, G1925195, G1925622, G1925623, G1925624, G1925625, G1925651, G1925652, G1925653, G1925654, G1925682, G1925683, G1925684, G1925685, G1925712, G1925713, G1925714, G1925715, G1925741, G1925742, G1926271, G1926272, G1926273, G1926274, G1926301, G1926302.
- Product
- Tibial knee prosthesis
- Recalling firm
- Smith & Nephew, Inc.
- Quantity
- 1,845 units
- Distribution
- Domestic Distribution: AL, LA ,MN, KY, AR, MN, GA, TX, WI, NJ, NC, CT, NY, OH, IA, IN, NC, MA, SC, NV, CT, WV, NY, OH, MN, MI, SC, TN, FL, AZ, PA and MO. International Distribution: Austria, Belgium, China, Canada, Switzerland, Colombia, Cyprus, Check Republic, Denmark, Spain, France, Great Britain, Greece, Hungary, India, Italy, Lithuania, Mexico, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Russia, Sweden, Slovenia, Turkey and Ukraine.
- Recall date
- August 19, 2020
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)