MicroAire Recalls Sterile Twist Drills Due to Incorrect Size Inclusion
MicroAire Surgical Instruments is recalling 42 sterile twist drills because one lot contained an incorrect 2.0mm drill alongside the correct 1.6mm drill.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device where using the wrong instrument size could cause injury, but no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
MicroAire Surgical Instruments, LLC is recalling 42 units of the SST Twist Drill, Standard, 1.6mm Dia. x 127mm (REF 8054-010, STERILE). These sterile instruments are intended for use in orthopaedic surgery to cut bone. The recall is limited to one lot identified by code LIT 0317305390, which was distributed within the United States.
The recall was initiated because one lot was found to contain both the correct 1.6mm twist drill and an incorrect 2.0mm twist drill. The presence of the incorrect size in a sterile surgical package poses a risk of using the wrong instrument during surgery.
Healthcare facilities and distributors should stop using the affected product and contact MicroAire Surgical Instruments for further instructions. Consumers are not directly affected as this is a professional medical device.
The recalled product
- 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
- Manufacturer
- MicroAire Surgical Instruments, LLC
- Affected units
- 42
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- LIT 0317305390
Distribution
Distribution scope not specified by the agency.
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