CLASS II ONGOING Device recall · Reported 15 Jul 2026 · FDA Enforcement Report

Empowr 3d Knee Ins, Ve recalled by Encore Medical

Encore Medical is recalling Empowr 3d Knee Ins, Ve, distributed in 14 states. The recall was initiated on 16 Feb 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel/Catalog Number: 342-19-703 Lot Code: Lot: 177T1057 GTIN: 00888912167703 Expiration Date: 12/07/2026

Quantity recalled4

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2700-2026
FDA event ID: 98700
Recalling firm: Encore Medical, Austin, TX
Classification: Class II
Status: Ongoing
Recall initiated: 16 Feb 2026
FDA classified: 8 Jul 2026
Reported: 15 Jul 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Hip & Knee Implants

Timeline

16 Feb 2026	Recall initiated by company
8 Jul 2026	Classified by FDA	+142 days
15 Jul 2026	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Due to packaging discrepancy with incorrect product size mixed up.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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.

Where it was distributed

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

Alabama Colorado Iowa Illinois Indiana Massachusetts Michigan Montana North Carolina Nebraska New York South Dakota Texas Wyoming

Questions about this recall

Why was it recalled?

Due to packaging discrepancy with incorrect product size mixed up.

Which lots are affected?

Model/Catalog Number: 342-19-703 Lot Code: Lot: 177T1057 GTIN: 00888912167703 Expiration Date: 12/07/2026

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 98700

Reported	Class	Recall	Company	Reason	Where
15 Jul 2026	CLASS II	Empowr 3d Knee Ins, Ve recalled by Encore Medical	Encore Medical	Packaging Defects	14 states

More recalls from Encore Medical

All 99

Reported	Class	Recall	Company	Reason	Where
15 Jul 2026Device	CLASS II	Empowr 3d Knee Ins, Ve recalled by Encore Medical	Encore Medical	Packaging Defects	14 states
4 Mar 2026Device	CLASS II	Empowr 3d Knee Ins, Ve recalled by Encore Medical	Encore Medical	Labeling Errors	Nationwide
4 Mar 2026Device	CLASS II	Reverse Shoulder Prosthesis recalled by Encore Medical	Encore Medical	Labeling Errors	Nationwide
4 Mar 2026Device	CLASS II	Reverse Shoulder Prosthesis recalled by Encore Medical	Encore Medical	Labeling Errors	Nationwide
11 Feb 2026Device	CLASS II	Empowr Acetabular System: Liner, 10 degree Hooded, HXe+, 36H recalled	Encore Medical	Packaging Defects	14 states

Other Hip & Knee Implants recalls

All 3,097

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
26 Aug 2026Device	CLASS II	Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation	Kico Knee Innovation	Device Malfunction	19 states
26 Aug 2026Device	CLASS II	Veritas Standard Reverse Total Shoulder Veritas Standard recalled	restor3d	Device Malfunction	Nationwide
19 Aug 2026Device	CLASS II	Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled	Waldemar Link GmbH & Co. KG (Mfg Site)	Other	IN
12 Aug 2026Device	CLASS II	U2 Total Knee System Femoral offset bushing recalled	United Orthopedic	Device Malfunction	Nationwide