The Recall Desk
HighFDA (Devices)·Z-1672-2023·Announced 2023-06-07

Partial Knee Implant Recall Due to Higher-Than-Expected Revision Rates

Smith & Nephew is recalling 2,146 cementless partial knee implants (ENGAGE system) due to complaint data showing 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: Class II medical device recall driven by complaint data indicating higher-than-expected revision rates compared to similar devices. No specific hospitalizations or illnesses explicitly reported, but the statistical signal represents increased risk requiring revision surgery.

Plain-English summary

Smith & Nephew, Inc. is recalling the ENGAGE Cementless Partial Knee System, Coated Tibial Tray, across all sizes and part numbers. Approximately 2,146 units were distributed nationwide in the United States.

Recent complaint data indicates that the revision rate for this device is trending higher than corresponding similar devices in global joint replacement registries. The data identifies a potential signal that device performance is an outlier versus the state of the art with respect to the risk for revision.

The recalled product

Product
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, SIZ
Manufacturer
Smith & Nephew, Inc.
Category
Medical Device — Orthopedic Knee Implant
Hazard
Affected units
2,146

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 1-10012-100
  • UDI/DI 00885556873113
  • b) REF 1-10012-150
  • UDI/DI 00885556873120
  • c) REF 1-10012-200
  • UDI/DI 00885556873137
  • d) REF 1-10012-250
  • UDI/DI 00885556873144
  • e) REF 1-10012-300
  • UDI/DI 00885556873151
  • f) REF 1-10012-350
  • UDI/DI 00885556873168
  • g) REF 1-10012-400
  • UDI/DI 00885556873175
  • h) REF 1-10012-450
  • UDI/DI 00885556873182
  • i) REF 1-10012-500
  • UDI/DI 00885556873199
  • j) REF 1-10012-550
  • UDI/DI 00885556873205

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Smith & Nephew, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Related recalls

Same manufacturer · Smith & Nephew, Inc.

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Same hazard · implant failure

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