Recall Z-0412-2018 ยท HTW Bit, Drill
MicroAire Surgical Instruments, LLC
SST TWIST DRILL, STANDARD, 1.6mm Dia. x 127mm, REF 8054-010, STERILE This product line is intended for use in orthopaedic surgery (large and small bone surgeries) to cut bone
| Date | May 22, 2017 |
| Status | Terminated |
| Reason | One lot was found to contain both the correct twist drill (1.6mm) as well as an incorrect twist drill (2.0mm) |
| Root cause | Labeling mix-ups |
| Action | MicroAire Surgical Instruments, LLC distributed recall letters on May 22, 2017 MicroAire Surgical Instruments, LLC distributed recall letters to the customers who received the mislabeled twist. Letters will be sent by UPS to expedite the delivery. For further questions, please call (434) 975-8000 |
| Quantity | 42 |
| Distribution | US Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.