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Use caution Medical device recall · FDA · Published September 21, 2018

Encore Medical: Exprt Precision Revision Hip System Recall - Loose Bolts Risk

Encore Medical recalls specific revision hip implants due to loose proximal body bolts that may cause pain or need for additional surgery. Affected models include 495-00-065 to 495-01-085.

🇺🇸 FDA recall #Z-1123-2019Medical deviceEncore Medical ›
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Recalling firmEncore Medical, Lp9800 Metric Blvd · Austin, TX 78758-5445
✎ GovInfoNow plain-language explainer

Encore Medical is recalling certain revision hip implants because loose bolts could cause pain or require additional surgery. This affects patients who received the specific model numbers listed in the recall. Read more at govinfonow.com/recall/69840-encore-medical-exprt-precision-revision-hip-system-recall-loose-bolts.

Source Summary by GovInfoNow · govinfonow.com/recall/69840-encore-medical-exprt-precision-revision-hip-system-recall-loose-bolts · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1123-2019

Cite this page

“Encore Medical: Exprt Precision Revision Hip System Recall - Loose Bolts Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/69840-encore-medical-exprt-precision-revision-hip-system-recall-loose-bolts. Based on FDA recall #Z-1123-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1123-2019%22&limit=1).

The FDA announced on Sept. 21, 2018, that Encore Medical, LP is recalling Exprt Precision System Revision Hip Proximal Bodies with bolts due to loose or improperly seated components. The agency stated the recall involves 22 units distributed across multiple states.

How to tell if you have it

  • Brand: Encore Medical
  • Product: Exprt Precision System: Revision Hip, Proximal Body with Bolt, Lateral Offset, Sterile R, djo surgical
  • REFs: 495-00-065, 495-00-075, 495-00-085, 495-01-065, 495-01-075, 495-01-085
  • Lots: All lots

The hazard

The FDA said complaints cited loose proximal body bolts or bolts found via x-ray as sitting above the proximal body rather than being properly seated. Patient risks associated with this defect may include pain, dissociation, and possible revision 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 product mix-up on Feb. 16, 2026, and an RSP Humeral Socket Insert labeling hazard on Jan. 15, 2026. Other recent recalls of similar products include Hologic 3D Mammography Systems Recall: Loose Bolts Risk (April 8, 2026) and U2 Total Knee System Femoral Offset Bushing Recall: Incorrect Implant Orientation Risk (March 19, 2026).

How to tell if you have this one

Check if your hip implant has model numbers 495-00-065, 495-00-075, 495-00-085, 495-01-065, 495-01-075, or 495-01-085. All lots of these models are affected.

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

What to do — step by step

  1. Check Your Implant Model

    Identify the model number on your hip implant to see if it matches the recalled numbers.

  2. Contact Your Surgeon

    Reach out to your surgeon to discuss whether your implant is affected and next steps.

Where it went and when

Where it was distributed

Distributed in 26 states.

Alaska: not listedAKMaine: yesMEVermont: not listedVTNew Hampshire: not listedNHWashington: yesWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: yesMNIllinois: yesILWisconsin: not listedWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: not listedMAOregon: not listedORNevada: yesNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: not listedNEMissouri: yesMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: yesAZNew Mexico: not listedNMKansas: not listedKSArkansas: yesARTennessee: yesTNNorth Carolina: not listedNCSouth Carolina: yesSCDistrict of Columbia: not listedDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: not listedHITexas: yesTXFlorida: yesFL

FDA distribution: “US: TN, MN, TX, CO, IL, IN, OH, SC, MS, MI, RI, PA, ME, NY, WA, MO, AR, OK, LA, AL, FL, GA, UT, AZ, CA, NV,.” 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, Louisiana, Maine, Michigan, Minnesota, Mississippi, Missouri, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Washington.

Recall timeline

FDA terminated this recall 2 years after the firm started it.

1. Firm started the recall: Sep 21, 201812. FDA classified it Class II: Apr 10, 201923. Published in FDA’s Enforcement Report: Apr 17, 201934. FDA terminated the recall: Sep 16, 2020420182020
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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

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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-1123-2019 (September 21, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1123-2019 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 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