The Recall Desk
HighFDA (Devices)·Z-2285-2025·Announced 2025-08-20

Knee implants recalled for incorrect size and side labeling

Encore Medical is recalling 18 EMPOWR 3D knee implants due to incorrect labeling showing wrong size and/or side. Mislabeled implants could result in the wrong device being used during surgery.

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 involving incorrect labeling on surgical implants where the wrong implant could potentially be placed during surgery. While no illnesses, injuries, or hospitalizations have been reported, the risk-of-harm nature of mislabeled surgical devices justifies a High severity rating per the rubric.

Plain-English summary

Encore Medical, LP is recalling 18 EMPOWR 3D Knee Tibial Insert - E-Plus implants (Model 341-16-704, Lot 148T1057) due to incorrect labeling. The implant labels contain incorrect information regarding implant size and/or side.

These knee implants are intended for use in knee replacement surgery. If the wrong implant is used due to the labeling error, it could affect surgical outcomes and function. The affected implants were distributed nationwide to surgical facilities in Alabama, Arizona, California, Colorado, Florida, Iowa, Illinois, Indiana, Kansas, Louisiana, New York, Tennessee, and Texas.

Suppliers and healthcare providers who received implants from this lot should verify that the actual implant specifications match the labeling before use in surgical procedures. Patients or providers with questions about whether they received one of these implants should contact their healthcare facility.

The recalled product

Product
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 4L 16MM, VE Model/Catalog Number: 341-16-704 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 — Surgical Implant / Orthopedic
Hazard
  • labeling-error
  • surgical-error-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 (1)

  • Lot Code: Item: 341-16-704 GTIN: 00888912167116 Lot\s: 148T1057

Distribution

Distributed nationwide across the United States.

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