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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Encore Medical, LP: DJO EMPOWR Knee Punch Handle Recalled for Tip Breakage Risk

Agency Publication Date: November 7, 2023
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Summary

Encore Medical, LP is recalling 406 units of the DJO EMPOWR Knee Punch Handle (REF: 801-05-040) because the instrument's tip may break during knee surgery. The defect is caused by a lack of proper heat treatment during manufacturing, which can lead to the metal tip snapping off while in use. If the handle tip breaks during a procedure, it could cause a disruption in the surgery or potentially leave metal fragments in the patient.

Risk

The lack of heat treatment makes the metal punch tip brittle and prone to fracturing under the mechanical stress of surgery. This can lead to surgical delays while staff locate and remove broken fragments, or may result in a piece of the instrument being left inside the surgical site.

What You Should Do

  1. Identify your device by checking for the DJO EMPOWR Knee Punch Handle, REF: 801-05-040 and UDI-DI: 00190446238881.
  2. Verify the lot number against the following affected codes: 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.
  3. Immediately stop using affected punch handles and sequester them to prevent use in future surgical procedures.
  4. Contact your healthcare provider or the manufacturer, Encore Medical (DJO), at 1-800-456-8696 or visit their website for specific return and replacement instructions.
  5. For additional questions or to report an issue, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Contact manufacturer for potential replacement or return.

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: DJO EMPOWR Knee Punch Handle
Model / REF:
801-05-040
UPC Codes:
00190446238881
Lot Numbers:
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

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93214
Status: Active
Manufacturer: Encore Medical, LP
Sold By: Hospitals; Surgical centers; Medical device distributors
Manufactured In: United States
Units Affected: 406
Distributed To: Virginia, Tennessee, Minnesota, Texas, Illinois, Indiana, Kentucky, Ohio, South Carolina, Mississippi, Rhode Island, Maine, New Jersey, New York, Maryland, California, Kansas, Louisiana, Puerto Rico, Alabama, Florida, Georgia, Arizona, Washington

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.