medical Class II Updated 2020-05-27

Howmedica Osteonics Corp. recalls Stryker Orthopaedics-Restoration Anatomic Hemispherical Shel

Recalled Product

Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 64 right, Sterile, Catalog # 504-02-64E-R, UDI (01)07613327012460(17)

Hazard / Issue

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.

Issued by

FDA

Distribution: 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
Lot/Code Info: Lot #s HP3142, J93277, HK4HK0, N18T96, 590V0J, WA1D8T, 6D4MT7, 2V3A9W, HE19E5, JN2DWN, 777N5V, YY4LXE, JA0986, 213804, 86112L, 8X4H1D, N25J45, EM8Y25, 647TEX, J011V3, N75WT3, H98AT2, JD1K8M, M576M5, 8Y64X7, E810LX, 7J2099, RH6TNE, HR6M1R, 101MM7, V76WAA, TX6X20, 8N36E0, 3T6330, MR025M, WL6T19, 9K2L3R, K53TKW, RT8P7Y, M82N19, 7E1R1Y, TJ56KK, RX8HHY, NJ4XWJ, WM5VVN
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