Z-2774-2020 Class II Ongoing
Recalled by Smith & Nephew, Inc.
— Memphis, TN
FDA device recall Z-2774-2020 was initiated by Smith & Nephew, Inc. on July 16, 2020 and is designated Class II. Reason for recall: Due to an inconsistency in the raw material process, specific lots may contain units with internal non-homogenous material defects. The recall status is ongoing. Affected quantity: 1,845 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 19, 2020
- Initiation Date
- July 16, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,845 units
Product Description
Tibial knee prosthesis
Reason for Recall
Due to an inconsistency in the raw material process, specific lots may contain units with internal non-homogenous material defects.
Distribution Pattern
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.
Code Information
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.