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U.S. Department of Health and Human Services

Class 2 Device Recall SMF STANDARD OFFSET

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  Class 2 Device Recall SMF STANDARD OFFSET see related information
Date Initiated by Firm February 19, 2019
Create Date March 20, 2019
Recall Status1 Terminated 3 on May 21, 2021
Recall Number Z-1029-2019
Recall Event ID 82193
510(K)Number K103256  
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
Product smith&nephew SMF(TM) HIGH OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1H SIZE, STEM, REF 713552511
Code Information 11CM01091T, 11EM12764T, 11EM12764U, 13MM16036B, 14GM13037D, 15MM09360A, 15MM10833A, 18CM24036 & 18EM15257
Recalling Firm/
Manufacturer		 Smith & Nephew, Inc.
1450 E Brooks Rd
Memphis TN 38116-1804
For Additional Information Contact David Snyder
978-7491440
Manufacturer Reason
for Recall		 Complaints were received indicating that the outer label incorrectly identified the product as size "1" instead of "-1". The product contained within the package is size "-1"
FDA Determined
Cause 2		 Packaging process control
Action The firm notified its direct accounts by email and letter on 02/18/2019. The notice requested return of the recalled products. Distributors were directed to notify their customers of the recall and ensure that the actions are carried out.
Quantity in Commerce 9 units
Distribution US: CA, TN, NC, AR, IN, FL, MO, and, Canada, China, France, Germany, Great Britain, India, Italy, Japan, Mexico, Poland, South Korea, Spain
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 = LPH and Original Applicant = SMITH & NEPHEW, INC.
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