Smith&Nephew ENGAGE Cementless Partial Knee System — Class II medical device recall Z-1670-2023
Ongoing recall by Smith & Nephew, Inc., reported 2023-06-07, distributed nationwide. Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devic
| Recall number | Z-1670-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew, Inc., Memphis, TN, United States |
| Recall initiated | 2023-05-02 |
| Classified | 2023-05-31 |
| Reported by FDA | 2023-06-07 |
| Distributed | Nationwide (US) |
| Quantity | 1,994 units |
| UPC / GTIN / UDI-DI | 00885556872925, 00885556872932, 00885556872949, 00885556872956, 00885556872963, 00885556872970, 00885556872987, 00885556872994, 00885556873007, 00885556873014, 00885556873021, 00885556873038, 00885556873045, 00885556873052, 00885556873069, 00885556873076 |
| Model numbers | 1-10003-100, 1-10003-110, 1-10003-200, 1-10003-210, 1-10003-300, 1-10003-310, 1-10003-400, 1-10003-410, 1-10003-500, 1-10003-510, 1-10003-600, 1-10003-610, 1-10003-700, 1-10003-710, 1-10003-800, 1-10003-810 |
Product
Smith&Nephew ENGAGE Cementless Partial Knee System, Porous Femoral components, Part Numbers: a) REF 1-10003-100 (SIZE 1 Right Medial); b) REF 1-10003-110 (SIZE 1 Left Medial); c) REF 1-10003-200 (SIZE 2-Right Medial); d) REF 1-10003-210 (SIZE 2-Left Medial); e) REF 1-10003-300 (SIZE 3- Right Medial); f) REF 1-10003-310 (SIZE 3- Left Medial); g) REF 1-10003-400 (SIZE 4- Right Medial); h) REF 1-10003-410 (SIZE 4- Left Medial); i) REF 1-10003-500 (SIZE 5- Right Medial); j) REF 1-10003-510 (SIZE 5- Left Medial); k) REF 1-10003-600 (SIZE 6- Right Medial); l) REF 1-10003-610 (SIZE 6- Left Medial); m) REF 1-10003-700 (SIZE 7- Right Medial); n) REF 1-10003-710 (SIZE 7- Left Medial); o) REF 1-10003-800, (SIZE 8 - Right Medial); p) REF 1-10003-810, (SIZE 8 - Left Medial); Unicondylar knee prothesis
Reason for recall
Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The data identifies a potential signal that the performance is an outlier versus the state of the art with respect to the risk for revision.
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-1670-2023. 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.