CLASS II ONGOING Device recall · Reported 23 Jul 2025 · FDA Enforcement Report

Empowr 3d Knee Tibial Insert - E-plus Empowr 3d Kneetm Ins, Ve recalled

Encore Medical is recalling Empowr 3d Knee Tibial Insert - E-plus Empowr 3d Kneetm Ins, Ve, distributed in 18 states. The recall was initiated on 2 Jun 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Code: Item: 341-12-711 GTIN: 00888912166980 Lot: 115T1077

Quantity recalled20

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-2126-2025
FDA event ID: 97048
Recalling firm: Encore Medical, Austin, TX
Classification: Class II
Status: Ongoing
Recall initiated: 2 Jun 2025
FDA classified: 17 Jul 2025
Reported: 23 Jul 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Hip & Knee Implants

Timeline

2 Jun 2025	Recall initiated by company
17 Jul 2025	Classified by FDA	+45 days
23 Jul 2025	Published in enforcement report	+6 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 the incorrect tibial inserts/implants being packaged. The use of this product may result in the incorrect product being selected. This could result in a revision surgery if used.

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 TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 12MM, VE Model/Catalog Number: 341-12-711 Software Version: NA Product Description: Enovis" knee devices are intended for treatment of patients who are candidates for knee arthroplasty per the Indication for use. While total knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients. Component: NA

Where it was distributed

U.S Distribution to states of: AZ, IA, ID, IL, IN, LA, MI, MO, MS, NE, NY, OK, OR, PR, SD, UT, VA, and WA

Arizona Iowa Idaho Illinois Indiana Louisiana Michigan Missouri Mississippi Nebraska New York Oklahoma Oregon Puerto Rico South Dakota Utah Virginia Washington

Questions about this recall

Why was it recalled?

Which lots are affected?

Lot Code: Item: 341-12-711 GTIN: 00888912166980 Lot: 115T1077

Where was it sold?

U.S Distribution to states of: AZ, IA, ID, IL, IN, LA, MI, MO, MS, NE, NY, OK, OR, PR, SD, UT, VA, and WA

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 97048

Reported	Class	Recall	Company	Reason	Where
23 Jul 2025	CLASS II	Empowr 3d Knee Tibial Insert - E-plus Empowr 3d Kneetm Ins, Ve recalled	Encore Medical	Packaging Defects	18 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
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

Other Hip & Knee Implants recalls

All 3,110

Reported	Class	Recall	Company	Reason	Where
30 Sep 2026Device	CLASS II	Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large recalled	New York Embroidery Studio	Packaging Defects	Nationwide
23 Sep 2026Device	CLASS II	Axle Pin Assy Large Elbow Cobalt Chrome recalled by Howmedica Osteonics	Howmedica Osteonics	Other	Nationwide
23 Sep 2026Device	CLASS II	Triathlon Hinge Insert Size 4 5612-p-411 Triathlon Hinge recalled	Howmedica Osteonics	Other	Nationwide
23 Sep 2026Device	CLASS II	Scorpio Recessed Metal Backed Patella 3045 recalled	Howmedica Osteonics	Foreign Material	Nationwide
23 Sep 2026Device	CLASS II	Bearing And Axle Bushing Assy Std Elbow C-m113-1-301 Krh recalled	Howmedica Osteonics	Other	Nationwide