The Recall Desk
HighFDA (Devices)·Z-1673-2023·Announced 2023-06-07

Smith & Nephew ENGAGE Knee System Recalled for Elevated Revision Risk

Smith & Nephew's ENGAGE Cementless Partial Knee System is being recalled due to higher-than-expected revision rates compared to similar devices. The recall affects 7,531 units distributed nationwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall with no reported patient injuries or hospitalizations. The hazard is based on registry data showing higher revision rates compared to similar devices, representing a potential performance risk without confirmed adverse events.

Plain-English summary

Smith & Nephew's ENGAGE Cementless Partial Knee System, specifically the Coated Tibial Insert component, is being recalled. The recall covers 7,531 units of various sizes distributed nationwide across multiple part numbers and configurations.

The recall is based on complaint data and registry information indicating that the revision rate for this device is trending higher than corresponding similar devices in global joint replacement registries. Revision refers to the need for additional surgery to remove or replace the implant. This higher-than-expected revision rate represents a potential performance signal compared to devices of similar design.

Patients who have received this knee implant should contact their surgeon or healthcare provider to discuss whether they have one of the affected devices and what follow-up care or monitoring may be appropriate. Healthcare providers and facilities should also review their inventory for affected part numbers and follow guidance from Smith & Nephew and the FDA.

The recalled product

Product
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 1-1
Manufacturer
Smith & Nephew, Inc.
Category
Medical Device — Orthopedic Knee Implant
Hazard
  • device-failure
  • revision-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed nationwide across the United States.

Related recalls

Same category