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U.S. Department of Health and Human Services

Class 2 Device Recall BIRMINGHAM HIP RESURFACING MODULAR HEAD

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  Class 2 Device Recall BIRMINGHAM HIP RESURFACING MODULAR HEAD see related information
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
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
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
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.
510(K) Database 510(K)s with Product Code = KWL and Original Applicant = SMITH & NEPHEW, INC.
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