Smith & Nephew Recalls Mislabelled Birmingham Hip Resurfacing Modular Heads
Smith & Nephew is recalling 16 Birmingham Hip Resurfacing Modular Heads in the US because they were incorrectly labeled as a different device type not cleared for US marketing.
What this means for you
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 explicitly states the issue is incorrect labeling and does not report any illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Smith & Nephew, Inc. is recalling 16 units of the Birmingham Hip Resurfacing Modular Head in the United States. The recall is due to incorrect labeling; the devices were labeled as the monoblock Birmingham Hip Modular Head, a labeling configuration that was not cleared for marketing in the US. The actual devices were monoblock Modular Femoral Heads intended for hemiarthroplasty use.
The affected devices are distributed worldwide, including in the US, France, UAE, Austria, Australia, Belgium, Canada, Switzerland, Germany, Denmark, Spain, Finland, UK, Hong Kong, Israel, India, Italy, Japan, South Korea, Netherlands, Norway, Poland, Portugal, Sweden, Singapore, Thailand, Turkey, and South Africa. The specific reference numbers involved include 74121238, 74121242, 74121246, 74121250, 74121254, 74121258, 74121338, 74121342, 74121346, 74121350, 74121354, 74121358, 74121438, 74121442, 74121446, 74121450, 74121454, 74121458, 74121538, 74121542, 74121546, 74121550, 74121554, 74121558, and 74121558.
Healthcare providers and patients should contact Smith & Nephew, Inc. for further instructions regarding the replacement or return of these devices. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- BIRMINGHAM HIP RESURFACING MODULAR HEAD, REF numbers: 74121238, MODULAR HEAD 38 MM -8MM 74121242, MODULAR HEAD 42 MM -8MM 74121246, MODULAR HEAD 46 MM -8MM 74121250, MODULAR HEAD 50 MM -8MM 74121254, MODULAR HEAD 54 MM -8MM 74121258, MODULAR HEAD 58 MM -8MM 74121338
- Manufacturer
- Smith & Nephew, Inc.
- Hazard
- Affected units
- 16
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.
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