Recall Z-0656-2010 ยท NBH Accessories, Arthroscopic
TAG Medical Corp.
Tornier Arthro Tunneler. For transossous fixation of tendons to bone in rotator cuff repair. Catalog Number: SMB000101
| Date | Jan 19, 2010 (initiated Dec 4, 2009) |
| Status | Terminated |
| Reason | Device failed to deploy the distal loop |
| Root cause | Process change control |
| Action | Medicsense, the US Agent notified the sole distributor Tornier Inc., Edina, MN of the recall and requested notification to users requesting to discontinue and return product. Letter to customers dated December 4, 2009. |
| Quantity | 60 UNITS |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.