Use caution Medical device recall · FDA · Published August 3, 2020

DJO EMPOWR Tibial Knee Punch Handle Recall: Loose Pin Risk

DJO recalls EMPOWR Tibial Knee Punch Handles with part numbers 801-05-040 and 801-05-018 due to potential pin loosening that could leave debris in the joint. Affected units have specific lot numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0060-2021Medical device DJO ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmEncore Medical, LP9800 Metric Blvd · Austin, TX 78758-5445

✎ GovInfoNow plain-language explainer

DJO is recalling two specific parts for their EMPOWR Knee system because a small pin might become loose during use, which could leave debris in the knee joint. This is a safety issue for people who have had knee surgery with this device. Read more at govinfonow.com/recall/64537-djo-empowr-tibial-knee-punch-handle-recall-loose-pin-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/64537-djo-empowr-tibial-knee-punch-handle-recall-loose-pin-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0060-2021

Cite this page

“DJO EMPOWR Tibial Knee Punch Handle Recall: Loose Pin Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64537-djo-empowr-tibial-knee-punch-handle-recall-loose-pin-risk. Based on FDA recall #Z-0060-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0060-2021%22&limit=1).

Encore Medical, LP recalled DJO EMPOWR Tibial Knee Punch Handles with specific lot numbers due to a potential for the retaining pin to become loose and fall out, according to the FDA. The agency announced the Class II recall on August 3, 2020.

How to tell if you have it

Brand: DJO
Product: EMPOWR Tibial Knee Punch Handle contained in Instrument Tray for EMPOWR Porous Knee
Part No.: 801-05-040 and 801-05-018
Lot/serial No.s: 281905L08, 281905L15, 283808L01, 305197L02, 318871L10 (for Part No. 801-05-040); 215488L08, 236760L01, 228231L01, 241946L02, 259710L01, 314969L01 (for Part No. 801-05-018)
Units affected: 190
Distribution: U.S. Nationwide including 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

The hazard

The FDA stated 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.

Context

GovInfoNow's records show Encore Medical, LP has had 43 other recalls on record since May 31, 2017. Recent recalls include the February 16, 2026 packaging mix-up for EMPOWR 3D KNEE Ins and the January 15, 2026 incorrect labeling hazard for RSP Humeral Socket Inserts. Other recent recalls of similar products include the December 4, 2025 Merit Medical Custom Procedure Kit recall and the April 22, 2026 Intuitive Surgical Da Vinci Surgical System recall.

How to tell if you have this one

Check for part numbers 801-05-040 or 801-05-018 in the DJO EMPOWR Tibial Knee Punch Handle. Affected units have specific lot/serial numbers listed in the recall notice.

Brand
DJO
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check for Recalled Parts
Look for part numbers 801-05-040 or 801-05-018 in the DJO EMPOWR Tibial Knee Punch Handle.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 26 states.

FDA distribution: “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.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, Arkansas, California, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maine, Maryland, Minnesota, Mississippi, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington.

Recall timeline

FDA published this recall 2 months after the firm started it.

Aug 3, 2020Firm started the recall
Oct 7, 2020FDA classified it Class II
Oct 14, 2020Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/64537-djo-empowr-tibial-knee-punch-handle-recall-loose-pin-risk">DJO EMPOWR Tibial Knee Punch Handle Recall: Loose Pin Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0060-2021 (August 3, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0060-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.