CLASS II ONGOING Device recall · Reported 15 Nov 2023 · FDA Enforcement Report

DJO Empowr Knee Punch Handle recalled by Encore Medical

Encore Medical is recalling DJO Empowr Knee Punch Handle, distributed in 24 states. The recall was initiated on 29 Sep 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI: 00190446238881, Lots: 305197L02D, 305197L02E, 318871L10D, 318871L10E, 305197L02B, 305197L02C, 318871L10B, 318871L10C, 325045L17A, 325045L17B, 325045L17C, 305197L02, 318871L10, 325045L17, 327669L03, 331146L01, 332158L06, 334314L04, 336735L04, 336801L01, 340391L01, 341961L01, 342586L01, 346101L01, 350076L01, 351106L02, 360277L01, 366833L03, 374648L01, 380510L01

Quantity recalled406

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-0258-2024
FDA event ID: 93214
Recalling firm: Encore Medical, Austin, TX
Classification: Class II
Status: Ongoing
Recall initiated: 29 Sep 2023
FDA classified: 7 Nov 2023
Reported: 15 Nov 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Hip & Knee Implants

Timeline

29 Sep 2023	Recall initiated by company
7 Nov 2023	Classified by FDA	+39 days
15 Nov 2023	Published in enforcement report	+8 days

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

Reason for recall

Knee punch handle tip is breaking during surgery due to the lack of heat treatment, which may lead to a disruption in surgery.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

DJO EMPOWR Knee Punch Handle, REF: 801-05-040

Where it was distributed

US: VA, TN, MN, TX, IL, IN, KY, OH, SC, MS, RI, ME, NJ, NY, MD, CA, KS, LA, PR, AL, FL, GA, AZ, WA

Alabama Arizona California Florida Georgia Illinois Indiana Kansas Kentucky Louisiana Maryland Maine Minnesota Mississippi New Jersey New York Ohio Puerto Rico Rhode Island South Carolina

Questions about this recall

Why was it recalled?

Knee punch handle tip is breaking during surgery due to the lack of heat treatment, which may lead to a disruption in surgery.

Which lots are affected?

UDI-DI: 00190446238881, Lots: 305197L02D, 305197L02E, 318871L10D, 318871L10E, 305197L02B, 305197L02C, 318871L10B, 318871L10C, 325045L17A, 325045L17B, 325045L17C, 305197L02, 318871L10, 325045L17, 327669L03, 331146L01, 332158L06, 334314L04, 336735L04, 336801L01, 340391L01, 341961L01, 342586L01, 346101L01, 350076L01, 351106L02, 360277L01, 366833L03, 374648L01, 380510L01

Where was it sold?

US: VA, TN, MN, TX, IL, IN, KY, OH, SC, MS, RI, ME, NJ, NY, MD, CA, KS, LA, PR, AL, FL, GA, AZ, 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.

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

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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