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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92286

4 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
May 02, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Smith & Nephew, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

4 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 4

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

Z-1670-2023
Recall number
Z-1670-2023
Initiated
May 02, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Smith & Nephew, Inc.
Quantity
1994 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

US Nationwide distribution.

device · product 2 of 4

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

Z-1671-2023
Recall number
Z-1671-2023
Initiated
May 02, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Smith & Nephew, Inc.
Quantity
1596 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

US Nationwide distribution.

device · product 3 of 4

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

Z-1672-2023
Recall number
Z-1672-2023
Initiated
May 02, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Smith & Nephew, Inc.
Quantity
2146 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

US Nationwide distribution.

device · product 4 of 4

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

Z-1673-2023
Recall number
Z-1673-2023
Initiated
May 02, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Smith & Nephew, Inc.
Quantity
7531 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

US Nationwide distribution.