Reported Jan 13, 2016 · Terminated
BIRMINGHAM HIP RESURFACING MODULAR HEAD, REF numbers: 74121238, MODULAR HEAD 38 MM -8MM 74121242, MODULAR HEAD 42 MM…
Smith & Nephew, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Smith & Nephew, Inc. · 1450 E Brooks Rd · Memphis, TN · 38116-1804
Is this the product you have?
- BIRMINGHAM HIP RESURFACING MODULAR HEAD
- REF numbers
74121238MODULAR HEAD 38 MM -8MM 74121242MODULAR HEAD 42 MM -8MM 74121246MODULAR HEAD 46 MM -8MM 74121250MODULAR HEAD 50 MM -8MM 74121254MODULAR HEAD 54 MM -8MM 74121258MODULAR HEAD 58 MM -8MM 74121338MODULAR HEAD 3 8MM -4 (SHORT) 74121342MODULAR HEAD 42 MM -4 (SHORT) 74121346MODULAR HEAD 46 MM -4 (SHORT) 74121350MODULAR HEAD 50 MM -4 (SHORT) 74121354MODULAR HEAD 54 MM -4 (SHORT) 74121358MODULAR HEAD 58 MM -4 (SHORT) 74121438MODULAR HEAD 38 MM +0 (MED) 74121442MODULAR HEAD 42 MM +0 (MED) 74121446MODULAR HEAD 46 MM +0 (MED) 74121450MODULAR HEAD 50 MM +0 (MED) 74121454MODULAR HEAD 54 MM +0 (MED) 74121458MODULAR HEAD 58 MM +0 (MED) 74121538MODULAR HEAD 38 MM +4 (LONG) 74121542MODULAR HEAD 42 MM +4 (LONG) 74121546MODULAR HEAD 46 MM +4 (LONG) 74121550MODULAR HEAD 50 MM +4 (LONG) 74121554MODULAR HEAD 54 MM +4 (LONG) 74121558MODULAR HEAD 58 MM +4 (LONG)
- Lot codes and dates
- All codes
- Amount recalled
- 16 units in US
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
The 16 devices distributed in the United States were incorrectly labeled as the monoblock Birmingham Hip Modular Head, with labeling not cleared for marketing in the US. The actual devices were monoblock Modular Femoral Head for hemiarthroplasty use.
This product could cause temporary or reversible health problems — stop using it.
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