Lower riskMedical device recall · FDA · Published February 16, 2026
Encore Medical EMPOWR 3D KNEE Ins 11L 14MM VE: Packaging Mix-Up Recall
Encore Medical recalls EMPOWR 3D KNEE INS 11L 14MM VE (model 342-19-703) due to incorrect product size packaging. This may cause confusion during knee surgery. No action needed as it's a packaging error, not a safety hazard.
Encore Medical is recalling a specific knee implant model due to a packaging mix-up that could lead to using the wrong size during surgery. This is not a safety hazard but a labeling error that might cause confusion for medical staff. Read more at govinfonow.com/recall/49982-encore-medical-empowr-3d-knee-ins-11l-14mm-ve-packaging.
“Encore Medical EMPOWR 3D KNEE Ins 11L 14MM VE: Packaging Mix-Up Recall.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/49982-encore-medical-empowr-3d-knee-ins-11l-14mm-ve-packaging. Based on FDA recall #Z-2700-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2700-2026%22&limit=1).
Encore Medical, LP recalled the EMPOWR 3D KNEE INS knee device due to a packaging discrepancy that may result in the incorrect product size being mixed in. The Food and Drug Administration announced the voluntary Class II recall on Feb. 16, 2026.
How to tell if you have it
Brand: Encore Medical
Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE
Model/Catalog Number: 342-19-703
Lot Code: 177T1057
GTIN/UPC: 00888912167703
The hazard
The recall is due to a packaging discrepancy where the incorrect product size was mixed up with the intended device. The FDA stated this error could lead to the use of wrong-sized implants during knee arthroplasty procedures.
Context
GovInfoNow's records show Encore Medical, LP has issued 43 other recalls since May 31, 2017. Recent similar recalls include an EMPOWR 3D KNEE implant labeling error on Jan. 15, 2026, and an EMPOWR Acetabular System packaging discrepancy on Jan. 5, 2026. Other recent recalls of similar products include a DJO SURGICAL FA S Altivate Reverse Glenoid Tray reamer binding risk (July 18, 2025), a Howmedica Triathlon Baseplate confusing labeling risk (May 19, 2026), a Straumann GM Helix Implant packaging mismatch (Aug. 12, 2026), and a Centinel Prodisc C SK U.S. Implant labeling mixup (March 20, 2026).
How to tell if you have this one
Check for the model number 342-19-703 on the packaging. The product was sold with lot code 177T1057 and expires December 2026.
Brand
Encore Medical
Product
Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 342-19-703 Product
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
GL112 Certus Medical LLC Indiana (IN) & Michigan (MI) 342-19-703 177T1057 EMPOWR 3D KNEETM INS, 3R 19MM, VE 1 MW001 Fox Medtech, LLC Colorado (CO), Wyoming (WY), Montana (MT), Counties in Nebraska 342-19-703 177T1057 EMPOWR 3D KNEETM INS, 3R 19MM, VE 1 NE190 Implant Medical Sales, Inc. New York (NY) 342-19-703 177T1057 EMPOWR 3D KNEETM INS, 3R 19MM, VE 1 SE180 Joint Medical Solutions, L.L.C. Alabama (AL) 342-19-703 177T1057 EMPOWR 3D KNEETM INS, 3R 19MM, VE 1 GL108 Great Lakes Medical Illiniois (IL) 341-14-711 135T1060 EMPOWR 3D KNEETM INS, 11L 14MM, VE 2 GL112 Certus Medical LLC Indiana (IN) & Michigan (MI) 341-14-711 135T1060 EMPOWR 3D KNEETM INS, 11L 14MM, VE 1 CE120 Matrix Orthopedics Surgical Devices Dallas/Fort Worth, TX 342-14-711 145T1067 EMPOWR 3D KNEETM INS, 11R 14MM, VE 1 NW105 Kinetic Medicine South Dakota (SD), Eastern Nebraska (NE), Western Iowa (IA) 342-14-711 145T1067 EMPOWR 3D KNEETM INS, 11R 14MM, VE 2 MA102 ProCore Medical LLC - NC North Carolina (NC) 342-14-711 145T1067 EMPOWR 3D KNEETM INS, 11R 14MM, VE 1 Total 11
Recall number
Product, codes & lots
Quantity
Z-2700-2026
Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 342-19-703 Product Description: Enovis knee devices are intended for knee arthroplasty.; Model/Catalog Number: 342-19-703 Lot Code: Lot: 177T1057 GTIN: 00888912167703 Expiration Date: 12/07/2026
4
Z-2701-2026
Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 341-14-711 Product Description: Enovis knee devices are for knee arthroplasty.; Model/Catalog Number: 341-14-711 Lot Code: Lot: 145T1067 and 135T1060 GTIN: 00888912167086 Expiration Date: 12-06-2026 (145T1067) 12-07-2026 (135T1060)
8
Based on the official FDA remedy
What to do — step by step
Verify Product Details
Check the model number on the packaging to confirm it's 342-19-703. This is the only affected model.
Where it went and when
Where it was distributed
Distributed in 13 states.
Listed by the agency
Not listed
FDA distribution: “GL112 Certus Medical LLC Indiana (IN) & Michigan (MI) 342-19-703 177T1057 EMPOWR 3D KNEETM INS, 3R 19MM, VE 1 MW001 Fox Medtech, LLC Colorado (CO), Wyoming (WY), Montana (MT), Counties in Nebraska 342-19-703 177T1057 EMPOWR 3D KNEETM INS,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, Colorado, Illinois, Indiana, Iowa, Michigan, Montana, Nebraska, New York, North Carolina, South Dakota, Texas, Wyoming.
Recall timeline
FDA published this recall 5 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2700-2026 (February 16, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2700-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.