The Recall Desk
HighFDA (Devices)·Z-2746-2015·Announced 2015-09-16

Smith & Nephew Birmingham Hip Resurfacing Acetabular Cup Recalled

Smith & Nephew is recalling specific Birmingham Hip Resurfacing Acetabular Cups because the system's revision rates were higher than established benchmarks.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a medical device with higher-than-benchmark revision rates, which fits the 'High' severity criteria for risk-of-harm products where specific injury reports are not detailed in the source text.

Plain-English summary

Smith & Nephew, Inc. is recalling the BIRMINGHAM HIP(TM) Resurfacing Acetabular Cup with Impactor. The affected reference numbers are 74120144, 74120146, 74122146, 74122148, 74120148, 74120150, 74122150, 74122152, 74120152, and 74120154. A total of 10,167 units are subject to this recall.

The recall was initiated because the firm observed that the BIRMINGHAM HIP(TM) Resurfacing (BHR) System had revision rates which were higher than established benchmarks. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

The product was distributed worldwide, including the United States and countries such as Australia, Austria, Bahrain, Belgium, Canada, China, Denmark, Finland, Germany, Hong Kong, Italy, Japan, Malaysia, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, and the United Arab Emirates. Patients who have had this device implanted should contact their healthcare provider for guidance.

The recalled product

Product
Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING ACETABULAR CUP W/IMPACTOR, REF Numbers: 74120144 (44 MM), 74120146 (46 MM), 74122146 (46 MM), 74122148 (48 MM), 74120148 (48 MM), 74120150 (50 MM), 74122150 (50 MM), 74122152 (52 MM), 74120152 (52 MM), 74120154 (54 MM) Product Us
Affected units
10,167

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 (1)

  • all codes

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 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 3 products in this recall →