CLASS II ONGOING Device recall · Reported 14 Oct 2020 · FDA Enforcement Report

DJO Empowr Tibial Knee Punch Handle recalled by Encore Medical

Encore Medical is recalling DJO Empowr Tibial Knee Punch Handle, distributed nationwide in the US. The recall was initiated on 3 Aug 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel/Catalog no. 801-05-040; :Lot/serial No.s 281905L08, 281905L15, 283808L01, 305197L02, 318871L10 Model/Catalog no. 801-05-018, Lot/serial No.s: 215488L08, 236760L01, 228231L01, 241946L02, 259710L01, 314969L01

Quantity recalled190 units

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-0060-2021
FDA event ID: 86257
Recalling firm: Encore Medical, Austin, TX
Classification: Class II
Status: Ongoing
Recall initiated: 3 Aug 2020
FDA classified: 7 Oct 2020
Reported: 14 Oct 2020
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Hip & Knee Implants

Timeline

3 Aug 2020	Recall initiated by company
7 Oct 2020	Classified by FDA	+65 days
14 Oct 2020	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

There is a potential for the retaining pin of the tibial punch handle to become loose and fall out while impacting. If undetected, there is a potential of leaving debris in the joint space.

Product as listed by the FDA

DJO EMPOWR Tibial Knee Punch Handle Part No. 801-05-040 and 801-05-018 contained in Instrument Tray for EMPOWR Porous Knee - Product Usage: The Tibial Punch Handle is used in conjunction with one of three appropriately sized Tibial Punch Guides to broach the tibial canal in preparation for the tibial baseplate keel.

Where it was distributed

U.S. Nationwide distribution including in the states of VA, TN, MN, TX, IL, IN, KY, OH, SC, RI, MD, PA, NY, CA, KS, OK, AR, LA, FL, AL, GA, AZ, NV, WA, MS, ME, NV and Puerto Rico.

Nationwide Alabama Arkansas Arizona California Florida Georgia Illinois Indiana Kansas Kentucky Louisiana Maryland Maine Minnesota Mississippi Nevada New York Ohio Oklahoma Pennsylvania

Questions about this recall

Why was it recalled?

There is a potential for the retaining pin of the tibial punch handle to become loose and fall out while impacting. If undetected, there is a potential of leaving debris in the joint space.

Which lots are affected?

Model/Catalog no. 801-05-040; :Lot/serial No.s 281905L08, 281905L15, 283808L01, 305197L02, 318871L10 Model/Catalog no. 801-05-018, Lot/serial No.s: 215488L08, 236760L01, 228231L01, 241946L02, 259710L01, 314969L01

Where was it sold?

U.S. Nationwide distribution including in the states of VA, TN, MN, TX, IL, IN, KY, OH, SC, RI, MD, PA, NY, CA, KS, OK, AR, LA, FL, AL, GA, AZ, NV, WA, MS, ME, NV and Puerto Rico.

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.

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