The Recall Desk
HighFDA (Devices)·Z-1670-2023·Announced 2023-06-07

Smith & Nephew ENGAGE Cementless Knee System Recalled Over Revision Rate Concerns

Smith & Nephew has recalled 1,994 units of its ENGAGE Cementless Partial Knee System because recent data shows higher-than-expected revision rates compared to similar devices.

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 based on statistical evidence of higher revision rates, but no specific illnesses or injuries are reported in the source material. It qualifies as a risk-of-harm product where injury has not yet been documented, warranting a High severity rating.

Plain-English summary

Smith & Nephew, Inc. is recalling 1,994 units of its ENGAGE Cementless Partial Knee System, a unicondylar knee prosthesis distributed nationwide. The recalled components are porous femoral parts (part numbers REF 1-10003-100 through REF 1-10003-810, all batches) used in knee replacement procedures.

The FDA Class II recall was issued based on recent complaint data showing that the revision rate for this device may be trending higher than comparable devices in global joint replacement registries. The data indicates the device's performance may be an outlier with respect to the risk of requiring revision surgery.

Patients who received this implant and their healthcare providers should be aware of this recall. Healthcare providers are advised to review this information and discuss any concerns with their patients. Patients should consult with their surgeon regarding their individual situation.

The recalled product

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-
Manufacturer
Smith & Nephew, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
  • implant-failure

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 1-10003-100
  • 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

Distribution

Distributed nationwide across the United States.

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