Recall Z-0584-2016 ยท KWL Prosthesis, Hip, Hemi-, Femoral, Metal
Smith & Nephew, Inc.
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, M
| Date | Nov 16, 2015 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Labeling design |
| Action | The firm sent their field safety notices on 11/16/2015 by letter delivered by Fed Ex (overnight) and email. Non- responding consignees will be contacted within 4 weeks of the initial notice |
| Quantity | 16 units in US |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061243 | SMITH & NEPHEW MODULAR FEMORAL HEAD Smith & Nephew, Inc., Jul 17, 2006 |