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U.S. Department of Health and Human Services

Class 2 Device Recall Tornier Latitude Elbow Prosthesis

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  Class 2 Device Recall Tornier Latitude Elbow Prosthesis see related information
Date Initiated by Firm June 23, 2011
Date Posted August 29, 2011
Recall Status1 Terminated 3 on July 17, 2012
Recall Number Z-3082-2011
Recall Event ID 59399
510(K)Number K100562  
Product Classification Prosthesis, elbow, semi-constrained, cemented - Product Code JDB
Product Latitude", Tige Humerale, Humeral Stem, Medium 77 mm, Humeral Stem Right, For Cemented use only, Sterile R, REF 0030402, Tornier In. Edina, MN 55435 USA.

The Tornier In. Latitude Elbow Prosthesis is intended for total elbow arthroplasty. Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability following the effects of primary or secondary osteoarthritis and rheumatoid arthritis; correction of functional deformities; revision procedures where other treatments or devices have failed; treatment of fractures that are unmanageable using others techniques. The Tornier In. Latitude Elbow Prosthesis is intended for cemented use only.
Code Information CC0810047
Recalling Firm/
Manufacturer		 Tornier, Inc
7701 France Ave S Ste 600
Edina MN 55435-3202
For Additional Information Contact
952-426-7600
Manufacturer Reason
for Recall		 Tornier has discovered that some models of the Tornier latitude Elbow Prosthesis (Small and Medium Humeral stems) were manufactured with a humeral screw that may not function as designed.
FDA Determined
Cause 2		 Process change control
Action Tornier, Inc. sent an "Urgent Product Correction" letter dated June 23, 2011. The letter was addressed to the doctors. The letter described the product and the problem. Doctors were insructed to monitor patients that have received the units for evidence of humeral screw loosening. For questions customers were instructed to contact the Customer Service Department at 1-888-494-7950.
Quantity in Commerce 3
Distribution Nationwide Distribution including FL and MO
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 = JDB and Original Applicant = TORNIER, INC.
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