FDAFDA · Food and drugs·Recall number Z-2088-2020
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 56 Right, Sterile, Catalog # 504-02-56D-R, UDI (01)07613327012347(17)
Published May 27, 2020 · Recall initiated: April 16, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Howmedica Osteonics Corp.
- Distributor
- 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
- Lot #s EE5WWV, DY6V66, 4T75EE, HT3X47, YX8KLL, 99554T, T58TR0, A46AJA, P23W2H, 9X0WHV, 681E6V, XP0AKD, RD53PW, R67PR4, N11PLW, WW20KE, KV6P9X, 6X4R9T, 2X4KLD, M08065, VN205Y, Y68MTM, EP6P1E, E257HE, PP894J, 4X47VL, 7J0H1A, K50T9R, 2E2139, V92X6Y, T42NM1, LV7LYM, RV8RWH, 2E5WH7, 8H3HK1, JV2PT1, PT243R, M30439, RH817R, XT5R2K, 112LE7, 4J485X, D360KK, PM5R68, KN48NR, LT1YKM, H82NXR, VP8MRR, 4Y44YM, V27D3P, N40RWX, YE2L2E, H500TT
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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