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U.S. Department of Health and Human Services

Class 2 Device Recall PROMOS Inclination set

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  Class 2 Device Recall PROMOS Inclination set see related information
Date Initiated by Firm January 14, 2010
Date Posted April 07, 2010
Recall Status1 Terminated 3 on April 10, 2012
Recall Number Z-1239-2010
Recall Event ID 54891
510(K)Number K063578  
Product Classification Inclination set - Product Code KWS
Product PROMOS Inclination set, SIZE 20mm, REF 42 180, S&N 75006722, QTY: (1), STERILE R, Smith & Nephew Orthopaedics AG, CH-Rotkreuz-Switzerland.

The device is used as a semi-constrained, metal/polymer cemented shoulder prosthesis.
Code Information All lots.
Recalling Firm/
Manufacturer		 Smith & Nephew Inc
1450 E. Brooks Rd
Memphis TN 38116
For Additional Information Contact Victor Rocha
901-399-6771
Manufacturer Reason
for Recall		 Firm received complaints of Inclination Set Screws fracturing.
FDA Determined
Cause 2		 Device Design
Action All affected Smith & Nephew Sales Representatives were notified of problem and the recall overnight mail on January 23, 2009. All affected Smith & Nephew International Distributors were notified via email and telephone on January 23, 2009. They were instructed to immediately quarantine the product for return to Stericycle, Inc., 2670 Executive Dr. Suite A Indianapolis, IN 46241. Direct questions to Smith & Nephew, Inc. by calling 1-901-399-6153.
Quantity in Commerce 1,597 units
Distribution Worldwide Distribution: United States, Australia, Austria, Belgium, China, Denmark, France, Germany, Greece, Great Britain, Italy, Netherlands, Poland, Portugal, Spain, Sweden and Switzerland.
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 = KWS and Original Applicant = PLUS ORTHOPEDICS AG
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