ZVplasty Directional Cement Cannula Long may lack adequate sterilization
Zavation is recalling 27 units of ZVplasty Directional Cement Cannula Long (Lot 20061365) used in orthopedic and spinal procedures due to inadequate sterilization. Products were distributed nationwide as sterile but may not have undergone proper sterilization processing.
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 recall of a surgical device due to potential sterilization failure. Although no illnesses or injuries have been reported, inadequate sterilization of surgical instruments used in invasive procedures poses a significant risk of post-operative infection, meeting the criteria for High severity.
Plain-English summary
Zavation Medical is recalling 27 units of the ZVplasty Directional Cement Cannula Long (REF VCF-1080-L, Lot 20061365), an orthopedic and spinal surgery instrument used for cement delivery during bone and joint procedures. The devices were distributed nationwide throughout the United States.
The recall was initiated because products distributed as sterile may not have been adequately sterilized. This means the instruments may not have undergone sufficient sterilization processing to ensure they are free from microbial contamination.
Patients who underwent procedures using these specific lot units could be at risk if the devices were inadequately sterilized. Healthcare providers who received these devices should quarantine them and not use them, and should contact Zavation for return or replacement instructions. Patients who may have received surgical treatment using these cannulas should consult their healthcare provider if they develop signs of infection.
The recalled product
- Product
- ZVplasty Directional Cement Cannula Long, REF VCF-1080-L. For use in Orthopedic / spinal procedures.
- Manufacturer
- Zavation
- Affected units
- 27
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: 20061365
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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