Smith & Nephew Recalls Birmingham Hip Resurfacing Femoral Heads for Labeling Defects
Smith & Nephew is recalling two Birmingham Hip Resurfacing Femoral Heads because they were distributed in the US with non-US labeling.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text identifies the issue as a labeling defect (missing US-approved IFU) rather than a physical defect or contamination, and no illnesses or injuries are reported.
Plain-English summary
Smith & Nephew, Inc. is recalling two units of the Birmingham Hip Resurfacing Femoral Head, specifically Size 58 mm (REF 74121158) and Size 56 mm (REF 74123156). The affected devices were distributed in Ohio, Texas, Colorado, Tennessee, Michigan, Pennsylvania, and New Jersey.
The recall was initiated because the devices, while manufactured to the same design specifications as US-approved products, did not contain the FDA-approved labeling required for US sale and use. Instead, they were distributed with Instructions for Use (IFU) intended for use outside of the United States.
Consumers and healthcare providers who have these specific devices should contact Smith & Nephew, Inc. for further instructions on how to proceed with the recall.
The recalled product
- Product
- Birmingham Hip Resurfacing Femoral Head: (a) Size 58 mm, REF 74121158 (b) Size 56 mm, REF 74123156
- Manufacturer
- Smith & Nephew, Inc.
- Hazard
- Affected units
- 2
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- (a) Size 58 mm
- REF 74121158
- Lot 16CW08945 (b) Size 56 mm
- REF 74123156
- Lot 16CW08246
Distribution
Part of a larger recall action
This product is one of 2 recalled by Smith & Nephew, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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