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
This recall has been terminated (originally issued May 22, 2017).
- Recall Initiated
- May 22, 2017
- Terminated
- August 29, 2018
- Recall Number
- Z-0412-2018
- Quantity
- 42
- Firm Location
- Charlottesville, VA
- Official Source
- View on FDA website ↗
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)
Distribution
US Distribution.
Lot / Code Info
LIT 0317305390
Root Cause
Labeling mix-ups
Action Taken
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
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