Skip to content
Lower risk Medical device recall · FDA · Published October 22, 2019

Encore Medical EMPOWR Acetabular System Recall: Fracturing Impactor Balls Risk

Encore Medical recalls EMPOWR Acetabular System models 803-15-023 to 803-15-030 due to fracturing impactor balls that could cause joint debris. Affected patients should contact manufacturer for details.

🇺🇸 FDA recall #Z-1929-2020Medical deviceEncore Medical ›
Take action

Contact the company

Recalling firmEncore Medical, LP9800 Metric Blvd · Austin, TX 78758-5445
✎ GovInfoNow plain-language explainer

Encore Medical is recalling specific models of EMPOWR Acetabular System implants because the impactor balls may fracture during use, potentially leaving debris in the joint. This could cause complications for patients who have received these implants. Read more at govinfonow.com/recall/66619-encore-medical-empowr-acetabular-system-recall-fracturing-impactor-balls-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/66619-encore-medical-empowr-acetabular-system-recall-fracturing-impactor-balls-risk · Updated August 10, 2026 · FDA enforcement record: FDA #Z-1929-2020

Cite this page

“Encore Medical EMPOWR Acetabular System Recall: Fracturing Impactor Balls Risk.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/66619-encore-medical-empowr-acetabular-system-recall-fracturing-impactor-balls-risk. Based on FDA recall #Z-1929-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1929-2020%22&limit=1).

The FDA announced on 2019-10-22 that Encore Medical, LP is recalling the Non-Sterile EMPOWR Acetabular System due to fracturing impactor balls that could leave debris in the joint. The agency issued recall number Z-1929-2020 for the voluntary Class II action.

How to tell if you have it

  • Brand: Encore Medical
  • Product: EMPOWR Acetabular System, Non-Sterile
  • Model Numbers: 803-15-023, 803-15-026, 803-15-027, 803-15-028, 803-15-029, 803-15-030
  • Quantity: 86 units

The hazard

The firm received complaints that the EMPOWR Acetabular Impactor Balls were fracturing or cracking during impaction, which could cause debris to migrate or be left in the joint space.

Context

GovInfoNow's records show Encore Medical, LP has 43 other recalls on record since 2017-05-31. Recent brand recalls include an EMPOWR 3D Knee Ins product mix-up on 2026-02-16 and an RSP Humeral Socket Insert labeling hazard on 2026-01-15. Other recent recalls of similar products include Howmedica SCORPIO C-DOME/PATELLA Implants (2026-07-30), Howmedica OMNIFIT Series I Acetabular Insert (2026-07-30), and Howmedica SCORPIO Patella Implants (2026-07-30).

How to tell if you have this one

Check if your EMPOWR Acetabular System implant has model numbers 803-15-023, 803-15-026, 803-15-027, 803-15-028, 803-15-029, or 803-15-030. The product is used in joint replacement surgeries for patients with conditions like osteoarthritis.

  • Brand
    Encore Medical
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Contact Manufacturer

    Reach out to Encore Medical directly for specific guidance on your implant model and next steps.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 7 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: nationwideWIMichigan: nationwideMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: named in the noticeINOhio: nationwideOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: named in the noticeVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: named in the noticeTXFlorida: nationwideFL

FDA distribution: “US Nationwide distribution including in the states of MN, VA, IL, IN, SC, N, TX, CA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Illinois, Indiana, Minnesota, South Carolina, Texas, Virginia.

Recall timeline

FDA published this recall 7 months after the firm started it.

1. Firm started the recall: Oct 22, 201912. FDA classified it Class II: May 8, 202023. Published in FDA’s Enforcement Report: May 20, 2020320192020
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

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

✎ GovInfoNow

Questions people ask

Do I need to stop using my implant immediately?

The recall does not require immediate discontinuation of use. Patients should contact Encore Medical for specific instructions.

Similar recalls

Latest medical device recalls

Keep exploring

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-1929-2020 (October 22, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1929-2020 to see it in context.
  • Plain-language summary written by qwen3:4b on August 10, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA