The Recall Desk
HighFDA (Devices)·Z-2286-2025·Announced 2025-08-20

EMPOWR 3D Knee Implants Recalled for Incorrect Size and Side Labeling

Encore Medical recalled 40 EMPOWR 3D knee implants because labels incorrectly specified implant size and/or side. The affected implants were distributed nationwide and patients should contact their healthcare provider if concerned.

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 medical device recall involving surgical knee implants with labeling errors specifying incorrect size and/or side. The product is a risk-of-harm device used in orthopedic surgery where implant size and side are critical. No injuries or illnesses have been reported in the source material, which limits the severity to High per the rubric.

Plain-English summary

Encore Medical, LP is recalling EMPOWR 3D Knee Tibial Insert - E-PLUS knee implants (Model 342-16-707) due to incorrect labeling of implant size and/or side. A total of 40 implants were affected.

The affected implants contain labels that incorrectly specify the size and/or side of the device. These implants are intended for patients undergoing knee arthroplasty (knee replacement surgery).

The affected implants were distributed nationwide to healthcare facilities in Alabama, Arizona, California, Colorado, Florida, Iowa, Illinois, Indiana, Kansas, Louisiana, New York, Tennessee, and Texas. The affected lot codes are 161T1053 and 161T1054.

Patients and healthcare providers who believe they may have received one of these implants should contact their surgeon or healthcare provider. Any implants found to be affected should be handled according to proper medical device management procedures.

The recalled product

Product
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 7R 16MM, VE Model/Catalog Number: 342-16-707 Product Description: Enovis knee devices are intended for treatment of patients who are candidates for knee arthroplasty per the Indication for use.
Manufacturer
Encore Medical, LP
Category
Medical Device — Orthopedic Implant
Hazard
  • mis-labeling
  • incorrect-sizing

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 (2)

  • Lot Code: Item: 342-16-707 GTIN: 00888912167642 Lot: 161T1053
  • 161T1054

Distribution

Distributed nationwide across the United States.

Related recalls

Same category