ZVplasty Surgical Bone Access Kit Recalled for Inadequate Sterilization
Zavation is recalling ZVplasty Direct Bipedicular Bone Access Kits because products distributed as sterile may not have been adequately sterilized. Affected lot numbers 19113043 and 20041107 were distributed nationwide.
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 Class II recall involves a surgical device with inadequate sterilization creating infection risk for spinal procedures. Per the severity rubric, this matches the criterion for High: 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Zavation is recalling ZVplasty Direct Bipedicular Bone Access Kits (model REF VCF-DDSKbd) because products distributed as sterile may not have been adequately sterilized. Affected lot numbers are 19113043 and 20041107, distributed nationwide in the United States.
Non-sterile or inadequately sterilized surgical instruments used in spinal procedures pose a risk of infection. The ZVplasty kit is designed for use in orthopedic and spinal surgical procedures.
Healthcare facilities should immediately discontinue use of affected lots and contact Zavation for instructions regarding return, replacement, or destruction. Patients who have undergone spinal procedures with these kits should consult their healthcare provider if they experience signs of infection.
The recalled product
- Product
- ZVplasty, Direct Bipedicular, Bone Access Kit with Coxaial Cannula, REF VCF-DDSKbd. For use in Orthopedic / spinal procedures.
- Manufacturer
- Zavation
- Affected units
- 2
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)
- Lot: 19113043
- 20041107
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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