CLASS II ONGOING Device recall · Reported 20 Aug 2025 · FDA Enforcement Report

Empowr 3d Knee Tibial Insert - E-plus Empowr 3d Knee Ins, 7r, Ve recalled

Encore Medical is recalling Empowr 3d Knee Tibial Insert - E-plus Empowr 3d Knee Ins, 7r, Ve, distributed nationwide in the US. The recall was initiated on 9 Jul 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Code: Item: 342-16-707 GTIN: 00888912167642 Lot: 161T1053, 161T1054

Quantity recalled40 implants

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-2286-2025
FDA event ID: 97188
Recalling firm: Encore Medical, Austin, TX
Classification: Class II
Status: Ongoing
Recall initiated: 9 Jul 2025
FDA classified: 8 Aug 2025
Reported: 20 Aug 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Hip & Knee Implants

Timeline

9 Jul 2025	Recall initiated by company
8 Aug 2025	Classified by FDA	+30 days
20 Aug 2025	Published in enforcement report	+12 days

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

Reason for recall

Knee implants contain incorrect labeling (size and/or side incorrect)

Product as listed by the FDA

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. 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.

Where it was distributed

US Nationwide distribution in the states of AL, AZ, CA, CO, FL, IA, IL, IN, KS, LA, NY, TN, TX.

Nationwide Alabama Arizona California Colorado Florida Iowa Illinois Indiana Kansas Louisiana New York Tennessee Texas

Questions about this recall

Why was it recalled?

Knee implants contain incorrect labeling (size and/or side incorrect)

Which lots are affected?

Lot Code: Item: 342-16-707 GTIN: 00888912167642 Lot: 161T1053, 161T1054

Where was it sold?

US Nationwide distribution in the states of AL, AZ, CA, CO, FL, IA, IL, IN, KS, LA, NY, TN, TX.

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 97188

This product is part of a recall event; the main page for the event is Empowr 3d Knee Tibial Insert - E-plus Empowr 3d Knee Ins, Ve recalled.

Reported	Class	Recall	Company	Reason	Where
20 Aug 2025	CLASS II	Empowr 3d Knee Tibial Insert - E-plus Empowr 3d Knee Ins, Ve recalled	Encore Medical	Labeling Errors	Nationwide

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

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All 3,110

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23 Sep 2026Device	CLASS II	Scorpio Recessed Metal Backed Patella 3045 recalled	Howmedica Osteonics	Foreign Material	Nationwide
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