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U.S. Department of Health and Human Services

Class 2 Device Recall 12/14 TAPER HIGH OFFSET NECK

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  Class 2 Device Recall 12/14 TAPER HIGH OFFSET NECK see related information
Date Initiated by Firm August 22, 2012
Date Posted September 20, 2012
Recall Status1 Terminated 3 on February 27, 2013
Recall Number Z-2427-2012
Recall Event ID 63089
510(K)Number K081124  
Product Classification Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate - Product Code MEH
Product 12/14 TAPER HIGH OFFSET NECK USE WITH SMITH & NEPHEW STEMS AND 12/14 FEMORAL COMPONENTS ONLY CO-CR, REF 71352112, Smith & Nephew, Inc. Memphis, TN 38116 USA.

USE WITH SMITH & NEPHEW STEMS AND 12/14 FEMORAL COMPONENTS.
Code Information Lot Numbers: 12FTM0017A, 12FTM0017B, 12FTM0017C, 12FTM0019A. 12FTM0019B, 12FTM0019C, 12FTM0019D, 12FTM0020A, 12FTM0020B, 12FTM0020C, 12FTM0021A, 12FTM0021B, and 12FTM0021C
Recalling Firm/
Manufacturer		 Smith & Nephew Inc
1450 E. Brooks Rd
Memphis TN 38116
For Additional Information Contact Joe Metzger
978-749-1330
Manufacturer Reason
for Recall		 Modular necks were manufactured out of specification by a vendor; the taper provide is undersized.
FDA Determined
Cause 2		 Employee error
Action Smith & Nephew sent an "URGENT:CLASS II RECALL-HIGH OFFSET MODULAR NECK R1213 letter dated August 22, 2012 to all affected customers. The letter identified the product, problem, and the actions to be taken by the customers. Customers were instructed to cease use and distribution of the product and quarantine for return. An Inventory Return Certification Form was included for customers to complete and return via fax to 901-566-7975.
Quantity in Commerce 70 units
Distribution Worldwide Distribution-USA (nationwide) including the states of CA, FL, GA, IL, IN, MA, NC, NJ, NY, OH, OK, PA, TN, TX, and WA, and the country of Canada.
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 = MEH and Original Applicant = SMITH & NEPHEW, INC.
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