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Lower risk Medical device recall · FDA · Published September 11, 2019

OMNI Hip System Model HC-00070: Missing Porous Coating Hazard

OMNIlife recalls hip replacement model HC-00070 due to missing porous coating. This could affect bone integration. Affected users should contact for remedy.

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

🇺🇸 FDA recall #Z-0169-2020Medical deviceOMNIlife ›
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Contact the company

Recalling firmOMNIlife science Inc.480 Paramount Dr · Raynham, MA 02767-1085
✎ GovInfoNow plain-language explainer

OMNIl:ife recalls hip replacement implants with model HC-00070 because they lack a critical porous coating. This may cause poor bone healing and long-term failure of the implant. Read more at govinfonow.com/recall/67043-omni-hip-system-model-hc-00070-missing-porous-coating-hazard.

Source Summary by GovInfoNow · govinfonow.com/recall/67043-omni-hip-system-model-hc-00070-missing-porous-coating-hazard · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0169-2020

Cite this page

“OMNI Hip System Model HC-00070: Missing Porous Coating Hazard.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/67043-omni-hip-system-model-hc-00070-missing-porous-coating-hazard. Based on FDA recall #Z-0169-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0169-2020%22&limit=1).

The FDA announced on 2019-09-11 that OMNIlife science Inc. voluntarily recalled the OMNI Hip System Model HC-00070 because stems are missing porous coating. The recall affects three units distributed in Oklahoma and Illinois.

How to tell if you have it

  • Brand: OMNIlife
  • Product: OMNI Hip System
  • Model/Order Number: HC-00070
  • Lot Code: 33035

The hazard

The device stems are missing the porous coating. The product is intended for use as the femoral component of a primary or revision total hip replacement.

Context

GovInfoNow's records show OMNIlife science Inc. has six other recalls on record since 2017-11-20. Other recent recalls of similar products include Howmedica Osteonics Recalls Hip Implant Components Due to Oxidation Risk (2026-07-30), Howmedica Osteonics Recalls Knee Implant Components Due to Oxidation Risk (2026-07-30), and Howmedica OMNIFIT Series I Acetabular Insert Recall: Oxidation Risk (2026-07-30).

How to tell if you have this one

Check for the model HC-00070, catalogue number, or order number HC-00070 on the implant. The lot number 33035 is also associated with this recall.

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

What to do — step by step

  1. Contact Manufacturer

    Reach out to OMNIlife science Inc. for guidance on next steps.

Where it went and when

Where it was distributed

Distributed in Illinois and Oklahoma.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: yesILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: yesOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: not listedFL

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

States: Illinois, Oklahoma.

Recall timeline

FDA terminated this recall 8 months after the firm started it.

1. Firm started the recall: Sep 11, 201912. FDA classified it Class II: Oct 21, 201923. Published in FDA’s Enforcement Report: Oct 30, 201934. FDA terminated the recall: Apr 27, 2020420192020
  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-0169-2020 (September 11, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0169-2020 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.
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