Use caution Medical device recall · FDA · Published September 29, 2023

Encore Medical DJO EMPOWR Knee Punch Handle Recall: Breaking Tip Disrupts Surgery

Encore Medical recalls DJO EMPOWR Knee Punch Handle (REF 801-05-040) due to breaking during surgery, risking surgical disruption. Affected units include specific lot numbers.

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

🇺🇸 FDA recall #Z-0258-2024Medical device Encore Medical ›

Use caution until it’s fixed

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

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

Encore Medical is recalling DJO EMPOWR Knee Punch Handles because the tip can break during surgery due to insufficient heat treatment. This could disrupt the surgical procedure and pose risks to patients. Read more at govinfonow.com/recall/57196-encore-medical-djo-empowr-knee-punch-handle-recall-breaking-tip.

Source Summary by GovInfoNow · govinfonow.com/recall/57196-encore-medical-djo-empowr-knee-punch-handle-recall-breaking-tip · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0258-2024

Cite this page

“Encore Medical DJO EMPOWR Knee Punch Handle Recall: Breaking Tip Disrupts Surgery.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57196-encore-medical-djo-empowr-knee-punch-handle-recall-breaking-tip. Based on FDA recall #Z-0258-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0258-2024%22&limit=1).

The FDA announced on Sept. 29, 2023, that Encore Medical, LP is recalling the DJO EMPOWR Knee Punch Handle due to a breaking tip hazard. The agency issued recall number Z-0258-2024 for the Class II device.

How to tell if you have it

Brand: Encore Medical
Product: DJO EMPOWR Knee Punch Handle
REF: 801-05-040
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
Units affected: 406

The hazard

According to the FDA, the knee punch handle tip may break during surgery because of a lack of heat treatment. This defect may lead to a disruption in surgery.

Context

GovInfoNow's records show Encore Medical, LP has issued 43 other recalls since May 31, 2017. Recent brand recalls include an EMPOWR 3D Knee Ins mix-up on Feb. 16, 2026, and labeling hazards for RSP Humeral Socket Inserts on Jan. 15, 2026. Other recent recalls of similar products include Merit Medical Custom Procedure Kit Recall (Dec. 4, 2025), Merit Medical Vascular Tray Recall (Dec. 4, 2025), and Merit Medical Custom Manifold Kit Recall (Dec. 4, 2025).

How to tell if you have this one

Check for the model reference 801-05-040 on the handle. Affected units include specific lot numbers listed in the recall notice.

Brand
Encore Medical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Lot Number
Look for lot numbers such as 305197L02D, 305197L02E, or 318871L10D on the handle.

Where it went and when

Where it was distributed

Distributed in 23 states and Puerto Rico.

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

States: Alabama, Arizona, California, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maine, Maryland, Minnesota, Mississippi, New Jersey, New York, Ohio, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington.

Recall timeline

FDA published this recall 47 days after the firm started it.

Sep 29, 2023Firm started the recall
Nov 7, 2023FDA classified it Class II
Nov 15, 2023Published 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/57196-encore-medical-djo-empowr-knee-punch-handle-recall-breaking-tip">Encore Medical DJO EMPOWR Knee Punch Handle Recall: Breaking Tip Disrupts Surgery (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-0258-2024 (September 29, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0258-2024 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.