FDA-Device2018-06-27Class II
Birmingham Hip Resurfacing Femoral Head: (a) Size 58 mm, REF 74121158 (b) Size 56 mm, REF 74123156
Smith & Nephew, Inc.
Hazard
The affected devices are manufactured to the same design specification as products intended for sale and use in the US but do not contain the FDA approved labeling (i.e., IFU and Patient Information Brochure). The affected devices were distributed in the US with the IFU intended for use outside of the US
Sold states
OH, TX, CO, TN, MI, PA, NJ
Affected count
2 units
Manufactured in
1450 E Brooks Rd, N/A, Memphis, TN, United States
Products
Birmingham Hip Resurfacing Femoral Head: (a) Size 58 mm, REF 74121158 (b) Size 56 mm, REF 74123156
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2267-2018Don't want to check this manually?
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