Reported May 27, 2020 · Terminated

Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 60 right, Sterile, Catalog # 504-02-60D-R, UDI…

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?

  • Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 60 right, Sterile, Catalog # 504-02-60D-R, UDI (01)07613327012408(17)
Lot codes and dates
    • Lot #s 9Y6675
    • 2J7WNV
    • A02X70
    • ME3841
    • P94D02
    • TD37HJ
    • DT8E38
    • LM49H5
    • WE24MT
    • 74064X
    • A36853
    • 694L07
    • YJ3J46
    • H26D71
    • 9X2RDX
    • AV6M23
    • L686MM
    • JY3288
    • MV2HXY
    • NP416P
    • 2L349V
    • XT6WTY
    • H02LL7
    • 601W6E
    • 6X855W
    • PV8H2X
    • R846J8
    • L705V1
    • D62TJ0
    • TM88WY
    • JE7AW0
    • 6W0DE9
    • 3400PT
    • D62345
    • 2E6E25
    • 422V52
    • 5R8KH0
    • VE2X77
    • W56APY
    • 8267AV
    • YH5N6L
    • P32YNV
    • T5091D
    • 4M46YJ
    • 7N4HW9
    • MM0T9T
    • XL0WKM
Amount recalled
4895

This recall covers 16 products

The agency filed one notice per product. You are reading one of them; the other 15 are below.

3 more are in the archive.

Where it was sold

Why it was recalled

The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris.

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

Want the full recall guide?

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Nov 15, 2021 · Data as of Sep 19, 6:13 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.