Recall Z-2294-2016 ยท HWC Screw, Fixation, Bone
MicroAire Surgical Instruments, LLC
Endotine Transbleph 3.5 (CFD-080-0167)
| Date | May 6, 2016 |
| Status | Terminated |
| Reason | MicroAire has initiated a limited recall (29 Units)on the Endotine Transbleph 3.5 (CFD-080-0167), Lot # 285373, due to minor mislabeling ( the front label is correct, but the side label lists an incorrect part number, i.e. CFD-080-0177). |
| Root cause | Labeling Change Control |
| Action | The firm is sending recall letters to the customers who have received the Endotine Transbleph 3.5 (CFD-080-0167), lot #285373. Letters sent by UPS to expedite the delivery. |
| Quantity | 29 |
| Distribution | The product was distributed in the United States and Sweden |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042796 | ENDOTINE TRANSBLEPH 3.0/3.5 DEVICE Coapt Systems, Inc., Nov 5, 2004 |