Device product
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 66 right, Sterile, Catalog # 504-02-66F-R, UDI (01)07613327012477(17)
Z-2097-2020
Product summary
- Event
- Event 85583
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4895
- Official record key
device-enforcement:Z-2097-2020
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 1X5DJK, NH4W8Y, 744EH9, AD25RA, 7E4HW3, 1N21NK, E00T60, WY1DD1, D26R36, H74H7L, RT0AK2, 593Y5R, AD00T8, E12H25, 9K66L6, AL7K8E, MP11MY, D04T4A, 8K74RX, 1R57DY, NH0352, KW5K62, 767RKK, V21PPJ, 6580X6, X73EDY, 5A1ANY, LJ0DWY, RR0T4W, JA761W, N11LR0, 1A03DE, 5E7XRM, TW81AP, 7E69MM, M42Y3R, A28827, 5N1DTH, Y6782W, J33J50, D930PJ, XR6WL0, TH4ED5, J54YNJ, D755P9
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
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.