FDA Device recall Z-1670-2023
Smith&Nephew ENGAGE Cementless Partial Knee System, Porous Femoral components, Part Numbers: a) REF 1-10003-100 (SIZE 1 Right Medial)
- FDA Device
- Class II
- ongoing
- Published 2023-06-07
On 2023-06-07 the FDA classified a Class II recall of Smith&Nephew ENGAGE Cementless Partial Knee System, Porous Femoral components, Part Numbers: a) REF 1-10003-100 (SIZE 1 Right Medial) by Smith And Nephew, citing 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 pote….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1670-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-05-02 |
| Published | 2023-06-07 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Smith And Nephew |
| Distribution | US |
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
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.
Identifiers
| code_info | a) REF 1-10003-100, UDI/DI 00885556872925; b) REF 1-10003-110, UDI/DI 00885556872932; c) REF 1-10003-200, UDI/DI 00885…a) REF 1-10003-100, UDI/DI 00885556872925; b) REF 1-10003-110, UDI/DI 00885556872932; c) REF 1-10003-200, UDI/DI 00885556872949; d) REF 1-10003-210, UDI/DI 00885556872956; e) REF 1-10003-300, UDI/DI 00885556872963; f) REF 1-10003-310, UDI/DI 00885556872970; g) REF 1-10003-400, UDI/DI 00885556872987; h) REF 1-10003-410, UDI/DI 00885556872994; i) REF 1-10003-500, UDI/DI 00885556873007; j) REF 1-10003-510, UDI/DI 00885556873014; k) REF 1-10003-600, UDI/DI 00885556873021; l) REF 1-10003-610, UDI/DI 00885556873038; m) REF 1-10003-700, UDI/DI 00885556873045; n) REF 1-10003-710, UDI/DI 00885556873052; o) REF 1-10003-800, UDI/DI 00885556873069; p) REF 1-10003-810, UDI/DI 00885556873076; ALL BATCHES |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1670-2023%22
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