FDA Device recall Z-2774-2020
Tibial knee prosthesis
- FDA Device
- Class II
- ongoing
- Published 2020-08-19
On 2020-08-19 the FDA classified a Class II recall of Tibial knee prosthesis by Smith And Nephew, citing due to an inconsistency in the raw material process, specific lots may contain units with internal non-homogenous material defects.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2774-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-07-16 |
| Published | 2020-08-19 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Smith And Nephew |
| Distribution | AL, AR, AZ, CT, FL, GA, IA, IN, KY, LA, MA, MI, MN, MO, NC, NJ, NV, NY, OH, PA, SC, TN, TX, WI, WV |
Product
Tibial knee prosthesis
Reason
Due to an inconsistency in the raw material process, specific lots may contain units with internal non-homogenous material defects.
Identifiers
| code_info | Model: 71420164; 71420166 and 71420184 Lot Numbers: 19MT31457, 19MT31458,19MT31459, 20AT32611, 20AT32612, 20AT32613…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, G1 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2774-2020%22
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