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U.S. Department of Health and Human Services

Class 2 Device Recall Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING FEMORAL HEAD,

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  Class 2 Device Recall Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING FEMORAL HEAD, see related information
Date Initiated by Firm June 03, 2015
Date Posted September 10, 2015
Recall Status1 Terminated 3 on January 21, 2017
Recall Number Z-2745-2015
Recall Event ID 71985
PMA Number P040033 
Product Classification Prosthesis, hip, semi-constrained, metal/metal, resurfacing - Product Code NXT
Product Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING FEMORAL HEAD, STERILE R, Rx only, REF Numbers: 74121138 (38 MM), 74123140 (40 MM), 74121142 (42 MM), 74123144 (44 MM), 74121146 (46 MM).

Product Usage: Hip joint prosthesis
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 firm observed that the BIRMINGHAM HIP(TM) Resurfacing (BHR) System had revision rates which were higher than established benchmarks.
FDA Determined
Cause 2		 Device Design
Action Smith & Nephew sent an notification letter dated June 3, 2015 to customers via E-mail and Fed- Ex. The letter identified the affected product, problem and actions to be taken. Customers were asked to quarantine the product and return it. Distributors were asked to notified their customers of the recall and ask them to return the product.
Quantity in Commerce 5,987 units
Distribution Worldwide Distribution - US Nationwide and countries of: Australia, Austria, Bahrain (UAE), Belgium, Canada, China, Denmark, Finland, Germany, Hong Kong, Italy, Japan, Malaysia, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand and United Arab Emirates (UAE).
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.
PMA Database PMAs with Product Code = NXT and Original Applicant = Smith & Nephew, Inc.
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