Z-2094-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 27, 2020
- Initiation Date
- April 16, 2020
- Termination Date
- November 15, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 64 left, Sterile, Catalog # 504-02-64E-L, UDI (01)07613327012484(17)
Reason for Recall
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.
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
Code Information
Lot #s Y32LP9, AN6ATN, A77J57, EE69A8, 625VEM, K8549T, EV6MXD, L85MMA, 7E2R48, M21Y21, H71N5N, A74YXL, PN2X3H, V2774X, AE6LJR, 7D0YJE, 6957YA, LM5N9M, 477ELH, JN8347, AY8T8N, EM0W77, TL29PE, NX79TH, 956DXP, A86VNH, KX5MX1, WW7VPM, 7A58DL, 37348T, N80109, 1269DY, 2351A5, H58V9W, 5M1K6H, T3509E, HL627T, WY1XP7, A76DE6, PX677J, AK4L6N, EA2MNR, AM5H8X, KM0M7W, D33PLA, 7R165A