ZVplasty Biopsy Device Lot 20061369 Recalled for Inadequate Sterilization
Zavation is recalling 162 units of the ZVplasty Biopsy Device (Lot 20061369) used in orthopedic and spinal procedures because they may not have been adequately sterilized.
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 an FDA Class II medical device recall for a surgical device used in orthopedic and spinal procedures. The hazard—inadequate sterilization—poses a risk of serious infection. No illnesses or injuries have been reported, making this a risk-of-harm situation without documented injury.
Plain-English summary
Zavation is recalling 162 units of the ZVplasty Biopsy Device, 10 Gauge (REF VCF-1010), designed for use in orthopedic and spinal procedures. The affected lot is 20061369 and was distributed nationwide.
According to the FDA, products from this lot were distributed as sterile but may not have been adequately sterilized. Inadequate sterilization poses a potential infection risk when these devices are used in surgical procedures.
Patients who have undergone orthopedic or spinal procedures using the ZVplasty Biopsy Device from the affected lot should be aware of this recall. Healthcare providers should contact Zavation for specific guidance and recall information.
The recalled product
- Product
- ZVplasty Biopsy Device, 10 Gauge, REF VCF-1010. For use in Orthopedic / spinal procedures.
- Manufacturer
- Zavation
- Affected units
- 162
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: 20061369
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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