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Recall Observatory FDA recall evidence

Device product

Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 56 Left, Sterile, Catalog # 504-02-56D-L, UDI (01)07613327012361(17)

Z-2086-2020

April 16, 2020

Class II

Product summary

Firm
Howmedica Osteonics Corp.
Event
Event 85583
Status
Terminated
Classification
Class II
Quantity
4895
Official record key
device-enforcement:Z-2086-2020

Official wording

Reason: 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.

Code information: Lot #s 4J3N24, W03J5W, N119A4, WK7K99, NM70TR, 3376L4, RK3XRL, RH27YA, M00KML, TM2MMK, PW30H8, DL01A0, WD4T0V, 2D40YA, 4Y5LAE, W63A8E, VJ34EV, AR5H0T, HY6Y45, KV2835, P84X94, KK0AVP, 2M8RW6, AL0AR3, TP1Y1H, W66X1L, PH28V2, P00606, 3Y3MHV, V32P52, EJ32W6, HN8HXP, 2V46PY, TD1A6J, 7R1X76, W62DKJ, N3435R, W92EP4, HJ0X8X, 5E3X1N, P53NP4, DJ2WKH, P32YRY, X62L47, XV86AL, XV2EY5, 108Y9R, T143LR, VH573D, W56T4K, A071R3, V319PM

Distribution pattern: Worldwide distribution including the following states: New York, Arkansas, Oklahoma, Michigan, Delaware, Texas, Louisiana, California, Florida, Arizona, Nevada, Ohio, Colorado, Rhode Island, Iowa, Pennsylvania, Massachusetts, North Carolina, Alabama, New Hampshire, Illinois, New Jersey, Virginia, Utah, Maryland, Mississippi, Missouri, Tennessee, Connecticut, and Kansas

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.