Latitude", Tige Humerale, Humeral Stem, Medium 77 mm, Humeral Stem Right, For Cemented use only, Sterile R, REF 0030402,
FDA device recall Z-3082-2011 · posted 2011-08-29 · Terminated
Recall details
- Recalling firm
- Tornier, Inc
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- JDB
- Quantity affected
- 3
- Distribution
- Nationwide Distribution including FL and MO
- Date initiated
- 2011-06-23
- Date posted
- 2011-08-29
- Date terminated
- 2012-07-17
- Location
- Edina, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LATITUDE ELBOW PROSTHESIS (K100562) | Tornier, Inc. | 2010-06-29 |