Smith & Nephew Birmingham Hip Resurfacing Femoral Head Recall
Smith & Nephew is recalling 5,987 units of the Birmingham Hip Resurfacing Femoral Head due to revision rates 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 involves a high-risk medical device (hip prosthesis) with performance issues (high revision rates) but no reported injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Smith & Nephew, Inc. is recalling 5,987 units of the BIRMINGHAM HIP(TM) Resurfacing Femoral Head. The product is a sterile, prescription-only hip joint prosthesis available in sizes ranging from 38 mm to 46 mm. The recall covers all codes and includes distribution across the United States and numerous international markets, including Australia, Canada, China, Germany, Japan, and the United Kingdom.
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. This indicates that the devices required surgical replacement at a frequency exceeding expected performance standards.
Healthcare providers and patients who have received this specific hip joint prosthesis should contact Smith & Nephew, Inc. for further instructions regarding the recall and potential replacement or monitoring options.
The recalled product
- Product
- Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING FEMORAL HEAD, STERILE R, Rx only, REF Numbers: 74121138 (38 MM), 74123140 (40 MM), 74121142 (42 MM), 74123144 (44 MM), 74121146 (46 MM). Product Usage: Hip joint prosthesis
- Manufacturer
- Smith & Nephew, Inc.
- Affected units
- 5,987
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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