Medline UNITE Foot & Ankle Drill Bit Recalled for Intra-operative Screw Failure Risk
Medline Industries recalls 190 UNITE foot and ankle drill bits due to observed screw failure during surgery. When used to pre-drill holes for certain screw sizes, the drill bits may fail under surgical torque, creating risk during procedures.
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: FDA Class II recall for surgical device with observed failure during actual use. No patient injuries or hospitalizations are reported in the source, which limits the severity to High rather than Severe under the rubric.
Plain-English summary
Medline Industries, LP has recalled 190 units of the MEDLINE UNITE FOOT & ANKLE DRILL BIT (1.3MM Solid Core, Model MPN10013). This surgical instrument is used in orthopedic foot and ankle procedures to pre-drill pilot holes for screws.
The recall was initiated due to observed intra-operative screw failure. When the 1.3mm drill bit is used to pre-drill holes for 2.0mm screws, or when a 1.6mm drill bit is used for 2.4mm screws, screw failure has been observed due to excessive torque. This defect creates a risk of equipment failure during surgical procedures.
The affected drill bits were distributed nationwide in the United States. Healthcare providers who have received this product should be aware of the recall and the associated failure risk.
The recalled product
- Product
- MEDLINE UNITE FOOT & ANKLE DRILL BIT, 1.3MM Solid Core, REF MPN10013
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- device-failure
- surgical-defect
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 (2)
- GTIN 10888277699113
- Lot Number ?
Distribution
Distributed nationwide across the United States.
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