Use caution Medical device recall · FDA · Published February 4, 2019

Encore Medical EMPOWR Locking Femoral Impactor Recall: Risk of Breakage and Misalignment

Encore Medical recalls EMPOWR Locking Femoral Impactor parts due to breakage risks and potential misalignment causing surgery delays or complications.

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

🇺🇸 FDA recall #Z-0611-2020Medical device Encore Medical ›

Use caution until it’s fixed

The firm has received reports/complaints concerning the breakage of the tips of the locking femoral Impactor. Additionally, if the impactor is not seated correctly on the implant prior to impaction, this may cause off axis loading which can increase the risk of device failure. This could cause a delay in surgery. If the tip is not seen during surgery, long term risks may include an inflammatory response, infection, and/ or pain

Take action

Contact the company

Recalling firmEncore Medical, Lp9800 Metric Blvd · Austin, TX 78758-5445

✎ GovInfoNow plain-language explainer

Encore Medical is recalling EMPOWR Locking Femoral Impactor parts (Part # 800-05-035) because they can break or become misaligned during surgery. This may cause delays, infections, or pain if not properly seated. Read more at govinfonow.com/recall/69053-encore-medical-empowr-locking-femoral-impactor-recall-risk-of-breakage.

Source Summary by GovInfoNow · govinfonow.com/recall/69053-encore-medical-empowr-locking-femoral-impactor-recall-risk-of-breakage · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0611-2020

Cite this page

“Encore Medical EMPOWR Locking Femoral Impactor Recall: Risk of Breakage and Misalignment.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69053-encore-medical-empowr-locking-femoral-impactor-recall-risk-of-breakage. Based on FDA recall #Z-0611-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0611-2020%22&limit=1).

Encore Medical, LP voluntarily recalled the EMPOWR Locking Femoral Impactor (Part # 800-05-035) packaged in instrument tray FA EMP PAT TOOL KIT (Part # 800-99-096), according to the FDA. The agency announced the Class II recall on Feb. 4, 2019, due to risks of tip breakage and off-axis loading.

How to tell if you have it

Brand: Encore Medical
Product: EMPOWR Locking Femoral Impactor, Part # 800-05-035
Packaging: Instrument tray FA EMP PAT TOOL KIT, Part # 800-99-096
Lots: All Lots
Quantity: 410 devices

The hazard

The firm received reports concerning the breakage of the tips of the locking femoral Impactor. If the impactor is not seated correctly on the implant prior to impaction, this may cause off-axis loading which can increase the risk of device failure. This could cause a delay in surgery, and if the tip is not seen during surgery, long-term risks may include an inflammatory response, infection, and/or pain.

Context

GovInfoNow's records show Encore Medical, LP has 43 other recalls on record since May 31, 2017. Recent brand recalls include the EMPOWR 3D Knee Ins 11L 14MM VE Product Mix-Up Recall (Feb. 16, 2026) and the Encore Medical RSP Humeral Socket Insert Recall (Jan. 15, 2026). Other recent recalls of similar products include the HFD100 Head Fixation Device Recall (Dec. 8, 2025), the U2 Total Knee System Femoral Valgus Adaptor Recall (May 20, 2026), and the U2 Total Knee System Femoral Offset Bushing Recall (March 19, 2026).

How to tell if you have this one

Check for the part number 800-05-035 in the instrument tray FA EMP PAT TOOL KIT (part # 800-99-096). All lots of this product are affected.

Brand
Encore Medical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Condition
Inspect the impactor for any signs of breakage or misalignment before use.
Contact Manufacturer
Reach out to Encore Medical for guidance on proper use or potential fixes.

Where it went and when

Where it was distributed

Distributed in 30 states and Puerto Rico.

FDA distribution: “CO, WA, CA, UT, CA, TN, TX, MS, MO, AR, OK, LA, MN, IL, IN, KY, OH, MI, PA, SC, FL, PR, AL, GA, NM, AZ, NV, VA, RI, MD, ME PA, NY OUS: None” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Arizona, Arkansas, California, Colorado, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Maine, Maryland, Michigan, Minnesota, Mississippi, Missouri, Nevada, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington.

Recall timeline

FDA published this recall 10 months after the firm started it.

Feb 4, 2019Firm started the recall
Dec 6, 2019FDA classified it Class II
Dec 18, 2019Published 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/69053-encore-medical-empowr-locking-femoral-impactor-recall-risk-of-breakage">Encore Medical EMPOWR Locking Femoral Impactor Recall: Risk of Breakage and Misalignment (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-0611-2020 (February 4, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0611-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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.