The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2268-2018·Announced 2018-06-27

Smith & Nephew Recalls Birmingham Hip Resurfacing Acetabular Cups for Labeling Defects

Smith & Nephew is recalling six Birmingham Hip Resurfacing Acetabular Cups because they were distributed in the US with international labeling instead of FDA-approved instructions.

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 discrepancy (missing FDA-approved IFU) rather than a defect causing injury or illness, fitting the 'Minor labeling errors' criterion for a Moderate score.

Plain-English summary

Smith & Nephew, Inc. is recalling six units of the Birmingham Hip Resurfacing Acetabular Cup with Impactor. The affected devices are manufactured to the same design specifications as products intended for sale and use in the United States. However, these specific units do not contain the FDA-approved labeling, which includes the Instructions for Use (IFU) and the Patient Information Brochure.

The recall was initiated because the affected devices were distributed in the US with the IFU intended for use outside of the United States. The specific units involved are sizes 54 mm, 56 mm, 58 mm, 60 mm, 62 mm, and 64 mm, with reference numbers 74122154, 74120156, 74122158, 74122160, 74122162, and 74120164, respectively.

The devices were distributed in Ohio, Texas, Colorado, Tennessee, Michigan, Pennsylvania, and New Jersey. Healthcare providers and patients who have received these specific devices should contact Smith & Nephew for instructions on how to proceed. The FDA has classified this as a Class II recall.

The recalled product

Product
Birmingham Hip Resurfacing Acetabular Cup with Impactor: (a) Size 56 mm, REF 74120156 (b) Size 64 mm, REF 74120164 (c) Size 54 mm, REF 74122154 (d) Size 58 mm, REF 74122158 (e) Size 60 mm, REF 74122160 (f) Size 62 mm, REF 74122162
Manufacturer
Smith & Nephew, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
6

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 (13)

  • (a) Size 56 mm
  • REF 74120156
  • Lot 16CW01824 (b) Size 64 mm
  • REF 74120164
  • Lot 16DW10975 (c) Size 54 mm
  • REF 74122154
  • Lot 16BW17747 (d) Size 58 mm
  • REF 74122158
  • Lot 16CW16199 (e) Size 60 mm
  • REF 74122160
  • Lot 08GW18001B (f) Size 62 mm
  • REF 74122162
  • Lot 16CW20851

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 →

Related recalls

Same manufacturer · Smith & Nephew, Inc.

See all →

Same hazard · mis labeling

See all →

Similar recalls