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Smith & Nephew, Inc. recalls Smith&Nephew ENGAGE Cementless Partial Knee System, Porous Femoral components, Part Numbers: a) REF 1-10003-100 (SIZ
Recalled June 7, 2023 · FDA recall Z-1670-2023 · Smith & Nephew
Hazard
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. · FDA Class II
Units
1994 units
Sold at
US Nationwide distribution.
Description
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.
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
Manufacturer(s)
Smith & Nephew, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →