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Use caution Medical device recall · FDA · Published July 21, 2017

Howmedica Accolade and Restoration Hip Products Recall: Sterile Barriers Not Fully Sealed

Howmedica recalls Accolade and Restoration hip implants with catalog numbers 6720-0837 and 6721-0737 due to potential contamination from unsealed sterile barriers.

🇺🇸 FDA recall #Z-0940-2018Medical deviceHowmedica ›
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Recalling firmHowmedica Osteonics Corp.325 Corporate Dr · Mahwah, NJ 07430-2006
✎ GovInfoNow plain-language explainer

What happened, in plain English

Howmedica is recalling Accolade and Restoration hip implants with specific catalog numbers because their sterile barriers might not be fully sealed. This could lead to contamination during surgery, which is a serious risk for patients. Read more at govinfonow.com/recall/73385-howmedica-accolade-and-restoration-hip-products-recall-sterile-barriers-not.

Source Summary by GovInfoNow · govinfonow.com/recall/73385-howmedica-accolade-and-restoration-hip-products-recall-sterile-barriers-not · Updated September 20, 2026 · FDA enforcement record: FDA #Z-0940-2018

Cite this page

“Howmedica Accolade and Restoration Hip Products Recall: Sterile Barriers Not Fully Sealed.” GovInfoNow, updated September 20, 2026. https://govinfonow.com/recall/73385-howmedica-accolade-and-restoration-hip-products-recall-sterile-barriers-not. Based on FDA recall #Z-0940-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0940-2018%22&limit=1).

Why it’s dangerous

The inner and outer sterile barriers in these hip implants may not be fully sealed. This could allow contaminants to enter the implant during surgery, increasing the risk of infection or other complications.

Who’s affected

Patients who received Accolade or Restoration hip implants with catalog numbers 6720-0837 or 6721-0737 are affected. Those who have had surgery with these implants are at the highest risk.

How to tell if you have this one

Check the catalog numbers on your hip implant: 6720-0837 or 6721-0737. These products were sold with specific lot numbers: 56211103, 56211401, 56211704, or 57284004.

  • Brand
    Howmedica
  • Category
    Medical device
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    Distributed in ten (10) states: AR, DE, FL, IL, IN, MI, NJ, OH, TN, and TX; and Canada, Sweden, United Kingdom, France, Spain, Italy, Japan, Romania, Colombia, Netherlands, and Australia.
Recall numberProduct, codes & lots
Z-0940-2018Accolade and Restoration hip product; Catalog Number: 6720-0837 and 6721-0737; Lot: 56211103, 56211401, 56211704, 57284004
Z-0941-2018Accolade and Restoration hip product; Catalog Number: 6021-0030, 6276-1-127, 6276-5-216, 6020-2530, 6020-4535, 6021-0740, 6021-0230, and 6021-4535; Lot: 55624702, 55709001, 55709002, 55709003, 55959003, 55967305, 56011203, 56011205, 56011301, 56019501, and 56109304
Based on the official FDA remedy

What to do — step by step

  1. Check Catalog Numbers

    Identify if your hip implant has catalog numbers 6720-0837 or 6721-0737.

  2. Contact Manufacturer

    Reach out to Howmedica Osteonics Corp. for further guidance on next steps.

Where it went and when

Where it was distributed

Distributed in 10 states, and outside the U.S.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: yesILWisconsin: not listedWIMichigan: yesMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: yesINOhio: yesOHPennsylvania: not listedPANew Jersey: yesNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: yesDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: yesARTennessee: yesTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: yesTXFlorida: yesFL

FDA distribution: “Distributed in ten (10) states: AR, DE, FL, IL, IN, MI, NJ, OH, TN, and TX; and Canada, Sweden, United Kingdom, France, Spain, Italy, Japan, Romania, Colombia, Netherlands, and Australia.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Arkansas, Delaware, Florida, Illinois, Indiana, Michigan, New Jersey, Ohio, Tennessee, Texas.

Recall timeline

FDA terminated this recall 2.6 years after the firm started it.

1. Firm started the recall: Jul 21, 201712. FDA classified it Class II: Mar 9, 201823. Published in FDA’s Enforcement Report: Mar 21, 201834. FDA terminated the recall: Mar 12, 2020420172020
  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-0940-2018 (July 21, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0940-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on September 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.
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