The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2267-2018·Announced 2018-06-27

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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.
Category
Medical Device — Orthopedic Implant
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

Distributed in 7 states:

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.

See all 2 products in this recall →

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