| Class 2 Device Recall BIRMINGHAM HIP RESURFACING MODULAR HEAD | |
Date Initiated by Firm | November 16, 2015 |
Create Date | January 05, 2016 |
Recall Status1 |
Terminated 3 on August 25, 2016 |
Recall Number | Z-0584-2016 |
Recall Event ID |
72719 |
510(K)Number | K061243 |
Product Classification |
Prosthesis, hip, hemi-, femoral, metal - Product Code KWL
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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, 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) |
Code Information |
All codes |
Recalling Firm/ Manufacturer |
Smith & Nephew, Inc. 1450 E Brooks Rd Memphis TN 38116-1804
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For Additional Information Contact | Joe Metzger 978-749-1330 |
Manufacturer Reason for Recall | 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. |
FDA Determined Cause 2 | 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 in Commerce | 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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = KWL
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