Food, drugs, devices › Smith & Nephew, Inc.

Device recall: Smith&Nephew ENGAGE Cementless Partial Knee System, Porous Femoral components, Part Numbers: a) REF 1-10003-100 (SIZE 1

FDA enforcement event 92286 · Class II · initiated 2 May 2023 · status Ongoing

DeviceVoluntary: Firm initiated4 product recordsMemphis, TN

Smith & Nephew, Inc. (Memphis, TN) initiated this device recall on 2 May 2023; FDA lists 4 product records under event 92286, classified Class II.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 917 device enforcement events initiated in 2023 carry the same class.

Status: Ongoing. Initiation: voluntary: firm initiated. Smith & Nephew, Inc. has 107 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Smith & Nephew, Inc., Memphis, TN.

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."

Distribution

"US Nationwide distribution."

Product records

Recall number	Product	Quantity	Class	Status	Report date
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…	1994 units	Class II	Ongoing	7 Jun 2023
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	1596 units	Class II	Ongoing	7 Jun 2023
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…	2146 units	Class II	Ongoing	7 Jun 2023
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…	7531 units	Class II	Ongoing	7 Jun 2023

Context

88%of 2023 device events are Class II917 events that year

4product records in this eventfirm median: 1

107events on this register for the firm

Other enforcement events for Smith & Nephew, Inc.

Initiated	Product (first record)	Type	Class	Records
16 Mar 2026	TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816	Device	Class II	1
24 Nov 2025	BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.	Device	Class II	1
18 Mar 2025	META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690	Device	Class II	1
29 Oct 2024	BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.	Device	Class II	1
15 Oct 2024	Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femo	Device	Class II	1
2 Oct 2024	smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 3 LEFT, REF 71421163; PROSTHESIS, KNEE, PATELL	Device	Class II	2
2 Oct 2024	smith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZE 5 LEFT, REF 71421015; Uncoated knee femur	Device	Class II	2
12 Aug 2024	ROTATION MEDICAL TENDON STAPLES (8) (broad indication)-Intended for fixation of prosthetic material to soft tissues. Pro	Device	Class II	2
9 Jul 2024	DIAMOND POINT, BOTH ENDS K-WIRE, REF 128042, metallic bone fixation fastener	Device	Class II	2
24 Apr 2024	smith&nephew OXINIUM Femoral Head 12/14 Taper, REF 71343204, 32 MM OD +4, Sterile; and smith&nephew, 12/14 Taper, REF 71	Device	Class II	1

All 107 events for Smith & Nephew, Inc.

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "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."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "US Nationwide distribution."

Is the recall still ongoing?

FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.