Tibial knee prosthesis — Class II medical device recall Z-2774-2020
Ongoing recall by Smith & Nephew, Inc., reported 2020-08-19, distributed in AL, AR, AZ, CT, FL, GA, IA, IN…. Due to an inconsistency in the raw material process, specific lots may contain units with internal non-homogen
| Recall number | Z-2774-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew, Inc., Memphis, TN, United States |
| Recall initiated | 2020-07-16 |
| Classified | 2020-08-07 |
| Reported by FDA | 2020-08-19 |
| Distributed | 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 |
| Countries outside the US | AT, BE, CA, CH, CN, CO, CY, DK, ES, FR, GB, GR, HU, IN, IT, LT, MX, NL, NO, PL, PT, RO, RS, RU, SE, SI, TR, UA |
| Quantity | 1,845 units |
| 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 and 88 more |
| Model numbers | 71420164 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2774-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.