Smith & Nephew, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0584-2016)

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, MODULAR HEAD 3 8MM -4 (SHORT) 74121342, MODULAR HEAD 42 MM -4 (SHORT) 74121346, MODULAR HEAD 46 MM -4 (SHORT) 74121350, MODULAR HEAD 50 MM -4 (SHORT) 74121354, MODULAR HEAD 54 MM -4 (SHORT) 74121358, MODULAR HEAD 58 MM -4 (SHORT) 74121438, MODULAR HEAD 38 MM +0 (MED) 74121442, MODULAR HEAD 42 MM +0 (MED) 74121446, MODULAR HEAD 46 MM +0 (MED) 74121450, MODULAR HEAD 50 MM +0 (MED) 74121454, MODULAR HEAD 54 MM +0 (MED) 74121458, MODULAR HEAD 58 MM +0 (MED) 74121538, MODULAR HEAD 38 MM +4 (LONG) 74121542, MODULAR HEAD 42 MM +4 (LONG) 74121546, MODULAR HEAD 46 MM +4 (LONG) 74121550, MODULAR HEAD 50 MM +4 (LONG) 74121554, MODULAR HEAD 54 MM +4 (LONG) 74121558, MODULAR HEAD 58 MM +4 (LONG)

Class II

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.

All codes

Worldwide distribution. US nationwide, 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.

Voluntary: Firm initiated