Stryker Orthopaedics-Restoration Anatomic Hemispherical recall
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 66 right, Sterile, Catalog # 504-02-66F-R, UDI (01)07613327012477(17)
Why was Stryker Orthopaedics-Restoration Anatomic Hemispherical recalled?
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 should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 66 right, Sterile, Catalog # 504-02-66F-R, UDI (01)07613327012477(17)
- Recalling firm
- Howmedica Osteonics Corp.
- Quantity
- 4895
- 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
- Recall date
- May 27, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)