10 Gauge Drill for Orthopedic Surgery Recalled for Sterilization Failure
Zavation recalled 58 units of 10 Gauge Drill (Lot 20102486) used in orthopedic/spinal procedures due to potential inadequate sterilization. Patients should contact their surgeon if they received treatment with an affected device.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 inadequate sterilization of surgical instruments used in spinal procedures. This is a risk-of-harm product where injury has not yet been reported, meeting the rubric criteria for High severity.
Plain-English summary
Zavation has recalled 58 units of its 10 Gauge Drill (model INTVM-DRL, Lot 20102486) used in orthopedic and spinal procedures. The devices were distributed nationwide and marketed as sterile products.
The FDA classified this as a Class II recall. The issue is that products distributed as sterile may not have been adequately sterilized.
Patients who underwent orthopedic or spinal procedures should consult their healthcare provider to determine whether they may have received treatment with an affected device.
The recalled product
- Product
- 10 Gauge Drill, CODE: INTVM-DRL. For use in Orthopedic / spinal procedures.
- Manufacturer
- Zavation
- Hazard
- Affected units
- 58
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)
- Lot: 20102486
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 71 recalled by Zavation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 71 products in this recall →Related recalls
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