EMPOWR 3D knee tibial inserts recalled over incorrect size or side labeling
Enovis is recalling 40 EMPOWR 3D Knee tibial inserts, catalog number 342-16-707, because the implants carry incorrect size or side labeling.
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; an implant labeled with the wrong size or side could be selected in surgery, and the notice reports no injuries.
Plain-English summary
The EMPOWR 3D Knee Tibial Insert - E-PLUS, product name EMPOWR 3D KNEE INS, 7R 16MM, VE, model and catalog number 342-16-707, is being recalled. The affected implants carry GTIN 00888912167642 and lot numbers 161T1053 and 161T1054. The recall covers 40 implants distributed in Alabama, Arizona, California, Colorado, Florida, Iowa, Illinois, Indiana, Kansas, Louisiana, New York, Tennessee and Texas.
The recall was issued because the knee implants contain incorrect labeling, with the size and/or side stated incorrectly. Enovis knee devices are intended for patients who are candidates for knee arthroplasty. The FDA classified the action as Class II.
Hospitals and surgical centres holding this catalog number should check the lot numbers above, quarantine affected stock and follow the manufacturer's instructions for return.
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
- Affected units
- 40
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
Part of a larger recall action
This product is one of 2 recalled by Encore Medical, LP 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 2 products in this recall →Related recalls
Same manufacturer · Encore Medical, LP
See all →- ModerateEMPOWR 3D Knee surgical device recalled due to packaging discrepancy
FDA (Devices) · 2026-07-15
- ModerateEMPOWR 3D KNEE insertion instruments recalled for incorrect product size packaging
FDA (Devices) · 2026-07-15
- SevereReverse Shoulder Prosthesis Implants Recalled Over Incorrect Labeling
FDA (Devices) · 2026-03-04
- HighShoulder prosthesis humeral socket inserts recalled over incorrect implant labeling
FDA (Devices) · 2026-03-04
- SevereKnee and Humeral Socket Implants Recalled for Incorrect Labeling
FDA (Devices) · 2026-03-04
Same hazard · mislabeling
See all →- ModerateOrthofix MINIRAIL External Fixation Devices Incorrectly Labeled
FDA (Devices) · 2026-07-22
- ModerateWise Onion Rings recalled for undeclared food color additives
FDA (Food) · 2026-07-15
- HighBakr Brown Butter Chocolate Chunk Cookie Dough Recalled for Undeclared Soy
FDA (Food) · 2026-07-15
- HighStapes prosthesis pistons carry an incorrect functional length on labeling
FDA (Devices) · 2026-06-10
- HighMedline eye trays contain insulin syringes labeled as tuberculin syringes
FDA (Devices) · 2026-06-03