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.
FDA Recall Z-3082-2011 · Posted 2011-08-29
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Recalling FirmTornier, Inc
Recall StatusTerminated
Product CodeJDB
Date Initiated2011-06-23
Date Terminated2012-07-17
Product Quantity3
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.
Firm 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.
Root Cause
Process change control
Distribution Pattern
Nationwide Distribution including FL and MO
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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