Recall Z-3082-2011 ยท JDB Prosthesis, Elbow, Semi-Constrained, Cemented
Tornier, Inc
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 osteoa
| Date | Aug 29, 2011 (initiated Jun 23, 2011) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 3 |
| Distribution | Nationwide Distribution including FL and MO |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100562 | LATITUDE ELBOW PROSTHESIS Tornier, Inc., Jun 29, 2010 |