Smith & Nephew, Inc. 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 1-10003-5 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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 1-10003-5
Brand
Smith & Nephew, Inc.
Lot Codes / Batch Numbers
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
Products Sold
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
Smith & Nephew, Inc. is recalling Smith&Nephew ENGAGE Cementless Partial Knee System, Porous Femoral components, Part Numbers: a) R due to Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registrie. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Smith & Nephew issued an Urgent Medical Device Recall Notice to its consignees on 05/02/2023 via email and letter. The notice explained the problem and the risk and requested the following: Required Actions: 1. Please inspect your inventory and locate any devices from the listed product and batch numbers enclosed with this Urgent Medical Device Recall Notice, and quarantine them immediately. a. If you are a sales rep, district office, or distributor, you must notify your customers of the field action and ensure that the required actions are complete. b. Include the customer s account number and name in Section A. 2. Please provide a copy of the attached Physician Communication to the surgical staff. The firm is seeking the return of the device.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026