Lower risk Medical device recall · FDA · Published May 2, 2023

Smith & Nephew ENGAGE Knee Implant Recall: Higher Revision Risk

Smith & Nephew recalls ENGAGE Cementless Partial Knee Systems with potential higher revision rates than similar devices. Affected models include REF 1-10011-100 to 300. No immediate action needed but monitor for complications.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1671-2023Medical device Smith & Nephew ›

Lower-risk 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.

Take action

Contact the company

Recalling firmSmith & Nephew, Inc.1450 E Brooks Rd · Memphis, TN 38116-1804

✎ GovInfoNow plain-language explainer

Smith & Nephew is recalling certain partial knee implants due to higher-than-expected revision rates compared to similar devices. This means some patients might need additional surgery more often than expected. The recall does not require immediate action but ongoing monitoring is advised. Read more at govinfonow.com/recall/58475-smith-nephew-engage-knee-implant-recall-higher-revision-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/58475-smith-nephew-engage-knee-implant-recall-higher-revision-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1671-2023

Cite this page

“Smith & Nephew ENGAGE Knee Implant Recall: Higher Revision Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58475-smith-nephew-engage-knee-implant-recall-higher-revision-risk. Based on FDA recall #Z-1671-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1671-2023%22&limit=1).

The FDA announced on May 2, 2023, that Smith & Nephew, Inc. is voluntarily recalling its ENGAGE Cementless Partial Knee System and Tibial Anchor Stem due to a potential outlier risk for revision surgery. The recall affects 1,596 units distributed nationwide in the U.S.

How to tell if you have it

Smith & Nephew ENGAGE Cementless Partial Knee System
Tibial Anchor Stem
REF 1-10011-100 (SIZE 1-2), UDI/DI 00885556873083
REF 1-10011-200 (SIZE 3-4), UDI/DI 00885556873090
REF 1-10011-300 (SIZE 5-6), UDI/DI 00885556873106
ALL BATCHES

The hazard

According to the FDA, recent complaint data indicates that the revision rate for these devices may be trending higher than corresponding similar devices in global joint replacement registries. The agency identified a potential signal that the performance is an outlier versus the state of the art with respect to the risk for revision.

Context

GovInfoNow's records show Smith & Nephew, Inc. has had 66 other recalls on record since July 24, 2017. Other recent recalls by the brand include the Smith & Nephew TRIGEN Humeral Nail Recall (March 16, 2026), the Smith & Nephew BIOSURE HA Screw Recall (Nov. 24, 2025), and the Smith & Nephew META-TAN Screw Kit Recall (March 18, 2025). Other recent recalls of similar products include the Howmedica SCORPIO Patella Implants Recall (July 30, 2026), the Arrowhead Implant Recall (June 23, 2026), and the Howmedica DURACON XL Angled Tibial Implants Recall (July 30, 2026).

How to tell if you have this one

Check if your implant has part numbers REF 1-10011-100 (size 1-2), REF 1-10011-200 (size 3-4), or REF 1-10011-300 (size 5-6). All batches of these models are affected.

Brand
Smith & Nephew
Category
Medical device

FDA recall event · 4 products

All 4 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
US Nationwide distribution.

Recall number	Product, codes & lots	Quantity
Z-1670-2023	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; 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	1994 units
Z-1671-2023	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	1596 units
Z-1672-2023	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 MEDIAL; k) REF 1-10012-600, SIZE 6-LEFT MEDIAL; l) REF 1-10012-650, SIZE 6-RIGHT MEDIAL; Unicondylar knee prothesis; 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	2146 units
Z-1673-2023	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) REF 1-10013-210, SIZE 2-LEFT MED, 10MM; k) REF 1-10013-211, SIZE 2-LEFT MED, 11MM; l) REF 1-10013-213, SIZE 2-LEFT MED, 13MM; m) REF 1-10013-259, SIZE 2-RIGHT MED, 9MM; n) REF 1-10013-260, SIZE 2-RIGHT MED, 10MM; o) REF 1-10013-261, SIZE 2-RIGHT MED, 11MM; p) REF 1-10013-263, SIZE 2-RIGHT MED, 13MM; q) REF 1-10013-309, SIZE 3-LEFT MED, 9MM; r) REF 1-10013-310, SIZE 3-LEFT MED, 10MM; s) REF 1-10013-311, SIZE 3-LEFT MED, 11MM; t) REF 1-10013-313, SIZE 3-LEFT MED, 13MM; u) REF 1-10013-359, SIZE 3-RIGHT MED, 9MM; v) REF 1-10013-360, SIZE 3-RIGHT MED, 10MM; w) REF 1-10013-361, SIZE 3-RIGHT MED, 11MM; x) REF 1-10013-363, SIZE 3-RIGHT MED, 13MM; y) REF 1-10013-409, SIZE 4-LEFT MED, 9MM; z) REF 1-10013-410, SIZE 4-LEFT MED, 10MM; aa) REF 1-10013-411, SIZE 4-LEFT MED, 11MM; bb) REF 1-10013-413, SIZE 4-LEFT MED, 13MM; cc) REF 1-10013-459, SIZE 4-RIGHT MED, 9MM; dd) REF 1-10013-460, SIZE 4-RIGHT MED, 10MM; ee) REF 1-10013-461, SIZE 4-RIGHT MED, 11MM; ff) REF 1-10013-463, SIZE 4-RIGHT MED, 13MM; gg) REF 1-10013-509, SIZE 5-LEFT MED, 9MM; hh) REF 1-10013-510, SIZE 5-LEFT MED, 10MM; ii) REF 1-10013-511, SIZE 5-LEFT MED, 11MM; jj) REF 1-10013-513, SIZE 5-LEFT MED, 13MM; kk) REF 1-10013-559, SIZE 5-RIGHT MED, 9MM; ll) REF 1-10013-560, SIZE 5-RIGHT MED, 10MM; mm) REF 1-10013-561, SIZE 5-RIGHT MED, 11MM; nn) REF 1-10013-563, SIZE 5-RIGHT MED, 13MM; oo) REF 1-10013-609, SIZE 6-LEFT MED, 9MM; pp) REF 1-10013-610, SIZE 6-LEFT MED, 10MM; qq) REF 1-10013-611, SIZE 6-LEFT MED, 11MM; rr) REF 1-10013-613, SIZE 6-LEFT MED, 13MM; ss) REF 1-10013-659, SIZE 6-RIGHT MED, 9MM; tt) REF 1-10013-660, SIZE 6-RIGHT MED, 10MM; uu) REF 1-10013-661, SIZE 6-RIGHT MED, 11MM; vv) REF 1-10013-663, SIZE 6-RIGHT MED, 13MM; Unicondylar knee prothesis; 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	7531 units

Based on the official FDA remedy

What to do — step by step

Monitor for Revision Symptoms
Contact your surgeon if you experience pain, swelling, or instability in the knee that worsens over time.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 36 days after the firm started it.

May 2, 2023Firm started the recall
May 31, 2023FDA classified it Class II
Jun 7, 2023Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/58475-smith-nephew-engage-knee-implant-recall-higher-revision-risk">Smith &amp; Nephew ENGAGE Knee Implant Recall: Higher Revision Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1671-2023 (May 2, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1671-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.