Recall Z-0412-2018— MicroAire Surgical Instruments, LLC
Class II · Terminated
Class II FDA medical device recall by MicroAire Surgical Instruments, LLC, initiated 2017-05-22, terminated 2018-08-29. FDA's recall record names no specific 510(k) clearance for this event. Product: 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. Reason: One lot was found to contain both the correct twist drill (1.6mm) as well as an incorrect twist drill (2.0mm).
- Recalling firm
- MicroAire Surgical Instruments, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-05-22
- Terminated
- 2018-08-29
- Firm location
- Charlottesville, VA, United States
Product description
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
Reason for recall
One lot was found to contain both the correct twist drill (1.6mm) as well as an incorrect twist drill (2.0mm)
Data sourced from openFDA. This site is unofficial and independent of the FDA.