CLASS II ONGOING Device recall · Reported 18 Oct 2023 · FDA Enforcement Report

Empowr 3D Knee Tibial Insert, 5R, VE recalled by Encore Medical

Encore Medical is recalling Empowr 3D Knee Tibial Insert, 5R, VE, distributed nationwide in the US. The recall was initiated on 22 Aug 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI: 00888912167321, Lot: 075T1167, Expiration: March 30, 2028

Quantity recalled36

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-0102-2024
FDA event ID: 93098
Recalling firm: Encore Medical, Austin, TX
Classification: Class II
Status: Ongoing
Recall initiated: 22 Aug 2023
FDA classified: 12 Oct 2023
Reported: 18 Oct 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Hip & Knee Implants

Timeline

22 Aug 2023	Recall initiated by company
12 Oct 2023	Classified by FDA	+51 days
18 Oct 2023	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

Knee insert and acetabular system parts were swapped within inner pack prior to the product being sealed within the tray, which could result in surgeons not having the correct product for the surgery due to different anatomies (Hip vs Knee).

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

EMPOWR 3D Knee Tibial Insert, 5R, 10MM, VE, REF: 342-10-705

Where it was distributed

US Nationwide distribution in the states of FL, CA, IN, HI, LA, MN, AZ, TX, NJ, PA, KS, TN, PR, SC, WA.

Nationwide Arizona California Florida Hawaii Indiana Kansas Louisiana Minnesota New Jersey Pennsylvania Puerto Rico South Carolina Tennessee Texas Washington

Questions about this recall

Why was it recalled?

Which lots are affected?

UDI-DI: 00888912167321, Lot: 075T1167, Expiration: March 30, 2028

Where was it sold?

US Nationwide distribution in the states of FL, CA, IN, HI, LA, MN, AZ, TX, NJ, PA, KS, TN, PR, SC, 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 93098

This product is part of a recall event; the main page for the event is Empowr Acetabular System, Liner, 10¿ Hooded, HXe+, 40H recalled.

Reported	Class	Recall	Company	Reason	Where
18 Oct 2023	CLASS II	Empowr Acetabular System, Liner, 10¿ Hooded, HXe+, 40H recalled	Encore Medical	Packaging Defects	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

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