Smith & Nephew, Inc.: 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.; 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 potenti

Agency Publication Date: May 31, 2023

Affected Products

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

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

Product: Smith&Nephew ENGAGE Cementless Partial Knee System, Tibial Anchor Stem, Part Numbers: a) REF 1-10011-100 (SIZE 1-2), b) REF 1-10011-200 (SIZE 3-4), c) REF 1-10011-300 (SIZE 5-6); Unicondylar knee prothesis

a) REF 1-10011-100, UDI/DI 00885556873083; b) REF 1-10011-200, UDI/DI 00885556873090; c) REF 1-10011-300, UDI/DI 00885556873106; ALL BATCHES

Product: Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Tray, Part Numbers: a) REF 1-10012-100, SIZE 1-LEFT MEDIAL; b) REF 1-10012-150, SIZE 1-RIGHT MEDIAL; c) REF 1-10012-200, SIZE 2-LEFT MEDIAL; d) REF 1-10012-250, SIZE 2-RIGHT MEDIAL; e) REF 1-10012-300, SIZE 3-LEFT MEDIAL; f) REF 1-10012-350, SIZE 3-RIGHT MEDIAL; g) REF 1-10012-400, SIZE 4-LEFT MEDIAL; h) REF 1-10012-450, SIZE 4-RIGHT MEDIAL; i) REF 1-10012-500, SIZE 5-LEFT MEDIAL; j) REF 1-10012-550, SIZE 5-RIGHT

a) REF 1-10012-100, UDI/DI 00885556873113; b) REF 1-10012-150, UDI/DI 00885556873120; c) REF 1-10012-200, UDI/DI 00885556873137; d) REF 1-10012-250, UDI/DI 00885556873144; e) REF 1-10012-300, UDI/DI 00885556873151; f) REF 1-10012-350, UDI/DI 00885556873168; g) REF 1-10012-400, UDI/DI 00885556873175; h) REF 1-10012-450, UDI/DI 00885556873182; i) REF 1-10012-500, UDI/DI 00885556873199; j) REF 1-10012-550, UDI/DI 00885556873205; k) REF 1-10012-600, UDI/DI 00885556873212; l) REF 1-10012-650, UDI/DI 00885556873229; ALL BATCHES

Product: Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Insert, Part Numbers: a) REF 1-10013-109, SIZE 1-LEFT MED, 9MM; b) REF 1-10013-110, SIZE 1-LEFT MED, 10MM; c) REF 1-10013-111, SIZE 1-LEFT MED, 11MM; d) REF 1-10013-113, SIZE 1-LEFT MED, 13MM; e) REF 1-10013-159, SIZE 1-RIGHT MED, 9MM; f) REF 1-10013-160, SIZE 1-RIGHT MED, 10MM; g) REF 1-10013-161, SIZE 1-RIGHT MED, 11MM; h) REF 1-10013-163, SIZE 1-RIGHT MED, 13MM; i) REF 1-10013-209, SIZE 2-LEFT MED, 9MM; j)

a) REF 1-10013-109, UDI/DI 885556873236; b) REF 1-10013-110, UDI/DI 885556873243; c) REF 1-10013-111, UDI/DI 885556873250; d) REF 1-10013-113, UDI/DI 885556873267; e) REF 1-10013-159, UDI/DI 885556873274; f) REF 1-10013-160, UDI/DI 885556873281; g) REF 1-10013-161, UDI/DI 885556873298; h) REF 1-10013-163, UDI/DI 885556873304; i) REF 1-10013-209, UDI/DI 885556873311; j) REF 1-10013-210, UDI/DI 885556873328; k) REF 1-10013-211, UDI/DI 885556873335; l) REF 1-10013-213, UDI/DI 885556873342; m) REF 1-10013-259, UDI/DI 885556873359; n) REF 1-10013-260, UDI/DI 885556873366; o) REF 1-10013-261, UDI/DI 885556873373; p) REF 1-10013-263, UDI/DI 885556873380; q) REF 1-10013-309, UDI/DI 885556873397; r) REF 1-10013-310, UDI/DI 885556873403; s) REF 1-10013-311, UDI/DI 885556873410; t) REF 1-10013-313, UDI/DI 885556873427; u) REF 1-10013-359, UDI/DI 885556873434; v) REF 1-10013-360, UDI/DI 885556873441; w) REF 1-10013-361, UDI/DI 885556873458; x) REF 1-10013-363, UDI/DI 885556873465; y) REF 1-10013-409, UDI/DI 885556873472; z) REF 1-10013-410, UDI/DI 885556873489; aa) REF 1-10013-411, UDI/DI 885556873502; bb) REF 1-10013-413, UDI/DI 885556873519; cc) REF 1-10013-459, UDI/DI 885556873526; dd) REF 1-10013-460, UDI/DI 885556873564; ee) REF 1-10013-461, UDI/DI 885556873601; ff) REF 1-10013-463, UDI/DI 885556873649; gg) REF 1-10013-509, UDI/DI 885556873670; hh) REF 1-10013-510, UDI/DI 885556873717; ii) REF 1-10013-511, UDI/DI 885556873762; jj) REF 1-10013-513, UDI/DI 885556873816; kk) REF 1-10013-559, UDI/DI 885556873854; ll) REF 1-10013-560, UDI/DI 885556873892; mm) REF 1-10013-561, UDI/DI 885556873939; nn) REF 1-10013-563, UDI/DI 885556873984; oo) REF 1-10013-609, UDI/DI 885556874028; pp) REF 1-10013-610, UDI/DI 885556874059; qq) REF 1-10013-611, UDI/DI 885556874097; rr) REF 1-10013-613, UDI/DI 885556874134; ss) REF 1-10013-659, UDI/DI 885556874196; tt) REF 1-10013-660, UDI/DI 885556874233; uu) REF 1-10013-661, UDI/DI 885556874288; vv) REF 1-10013-663, UDI/DI 885556874318; ALL BATCHES

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92286

Status: Active

Manufacturer: Smith & Nephew, Inc.

Manufactured In: United States

Units Affected: 4 products (1994 units; 1596 units; 2146 units; 7531 units)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

a) REF 1-10011-100, UDI/DI 00885556873083; b) REF 1-10011-200, UDI/DI 00885556873090; c) REF 1-10011-300, UDI/DI 00885556873106; ALL BATCHES