🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: May 2, 2023 Smith & Nephew Implants & Prosthetics Nationwide

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Smith & Nephew, Inc.
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

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

Product Codes/Lot 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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1670-2023

Related Recalls

META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690

Smith & Nephew

Class I - Dangerous

Integrated Lag/Compression Screw Kit has a compression screw with hexagon socket that may be undersized, which causes the screw to be non-functional, which would require replacement with another adequate size screw, and exchange may exceed 30 minutes.

Mar 18, 2025 Other Medical Devices Nationwide View Details →