Zavation Coaxial Cannula Lot 20102495 Recalled for Inadequate Sterilization
Zavation's 10G Coaxial Cannula with Tuohy Connection (Lot 20102495) used in spinal and orthopedic procedures has been recalled due to inadequate sterilization. Patients should contact their healthcare provider if they received this product.
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: This is a risk-of-harm medical device product where injury has not been reported. A surgical instrument intended for invasive procedures with inadequate sterilization presents serious potential for patient harm, meeting the criteria for High severity despite the absence of reported illnesses or injuries.
Plain-English summary
Zavation has recalled the 10G Coaxial Cannula with Tuohy Connection (CODE: INTVM-CC, Lot 20102495) used in orthopedic and spinal procedures. The device was distributed nationwide in the United States.
The recall was issued because the devices distributed as sterile may not have been adequately sterilized. Non-sterile surgical instruments used in invasive procedures present a risk of patient harm.
Patients who received this device during a spinal or orthopedic procedure should contact their healthcare provider to determine if they were affected. Healthcare providers should review records to identify patients who received affected devices.
Anyone with questions about this recall should contact the manufacturer or consult their healthcare provider.
The recalled product
- Product
- 10 G Coxaxial Cannula with Tuohy Connection, CODE: INTVM-CC. For use in Orthopedic / spinal procedures.
- Manufacturer
- Zavation
- Hazard
- Affected units
- 10
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: 20102495
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.
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