Reported Mar 21, 2018 · Terminated

Accolade and Restoration hip product; Catalog Number: 6021-0030, 6276-1-127, 6276-5-216, 6020-2530, 6020-4535,…

Howmedica Osteonics Corp.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Howmedica Osteonics Corp. · 325 Corporate Dr · Mahwah, NJ · 07430-2006

Is this the product you have?

  • Accolade 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 codes and dates
  • Lot
    • 55624702
    • 55709001
    • 55709002
    • 55709003
    • 55959003
    • 55967305
    • 56011203
    • 56011205
    • 56011301
    • 56019501
    • and 56109304
Amount recalled
255

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

Why it was recalled

Inner and outer sterile barriers not fully sealed.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Mar 12, 2020 · Data as of Sep 19, 4:49 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.