The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1671-2023·Announced 2023-06-07

Smith & Nephew Knee Prosthesis Recalled Due to Higher-Than-Expected Revision Rate

Smith & Nephew is recalling 1,596 units of its ENGAGE Cementless Partial Knee System due to complaint data indicating higher revision rates than comparable devices. Patients should consult their surgeon.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 a Class II medical device recall based on complaint data indicating higher-than-expected revision rates. No illnesses, injuries, or deaths are reported. This qualifies as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Smith & Nephew, Inc. is recalling 1,596 units of the ENGAGE Cementless Partial Knee System, Tibial Anchor Stem (a unicondylar knee prosthesis), distributed nationwide in the United States. The recall affects three part numbers: REF 1-10011-100 (Size 1-2), REF 1-10011-200 (Size 3-4), and REF 1-10011-300 (Size 5-6), across all manufacturing batches.

The recall was initiated after complaint data indicated that the device's revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The FDA identifies this as a potential signal that the device's performance differs from comparable devices with respect to the risk of requiring revision surgery.

Patients who have received this device should discuss their individual situation with their orthopedic surgeon. Questions or concerns about this recall can be directed to Smith & Nephew or the patient's healthcare provider.

The recalled product

Product
Smith&Nephew ENGAGE Cementless Partial Knee System, Tibial Anchor Stem, Part Numbers: a) REF 1-10011-100 (SIZE 1-2), b) REF 1-10011-200 (SIZE 3-4), c) REF 1-10011-300 (SIZE 5-6); Unicondylar knee prothesis
Manufacturer
Smith & Nephew, Inc.
Category
Medical Device — Orthopedic Joint Implant
Hazard
Affected units
1,596

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 (7)

  • a) REF 1-10011-100
  • UDI/DI 00885556873083
  • b) REF 1-10011-200
  • UDI/DI 00885556873090
  • c) REF 1-10011-300
  • UDI/DI 00885556873106
  • ALL BATCHES

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 →

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