medical Class II Updated 2018-06-27

Smith & Nephew, Inc. recalls Birmingham Hip Resurfacing Femoral Head: (a) Size 58 mm, RE

Recalled Product

Birmingham Hip Resurfacing Femoral Head: (a) Size 58 mm, REF 74121158 (b) Size 56 mm, REF 74123156


Hazard / Issue

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

Issued by

FDA

Affected States: OH, TX, CO, TN, MI, PA, NJ
Lot/Code Info: (a) Size 58 mm, REF 74121158, Lot 16CW08945 (b) Size 56 mm, REF 74123156, Lot 16CW08246
View official government recall

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →