Smith & Nephew Birmingham Hip Resurfacing Dysplasia Cup Recall
Smith & Nephew is recalling Birmingham Hip Resurfacing Dysplasia Cups because the system showed higher revision rates 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 high-risk medical device (hip prosthesis) with performance issues (higher revision rates), but the source text does not report specific injuries, hospitalizations, or fatalities, placing it in the 'High' category per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Smith & Nephew, Inc. is recalling the BIRMINGHAM HIP(TM) Resurfacing Dysplasia Cup with Impactor. The affected reference numbers are 74120246 (46 MM), 74122248 (48 MM), 74120250 (50 MM), 74122252 (52 MM), and 74120254 (54 MM). The product is a hip joint prosthesis.
The recall was initiated because the firm observed that the BIRMINGHAM HIP(TM) Resurfacing (BHR) System had revision rates that were higher than established benchmarks. The agency has classified this as a Class II recall.
A total of 624 units were distributed worldwide, including in the United States and various international markets. Patients who have had this specific hip resurfacing implant should contact their healthcare provider to discuss their individual situation and potential options.
The recalled product
- Product
- Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING DYSPLASIA CUP W/IMPACTOR, REF Numbers: 74120246 (46 MM), 74122248 (48 MM), 74120250 (50 MM), 74122252 (52 MM), 74120254 (54 MM) Product Usage: Hip joint prosthesis
- Manufacturer
- Smith & Nephew, Inc.
- Affected units
- 624
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.
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