ZVplasty orthopedic surgical devices may lack adequate sterilization
Zavation is recalling 24 units of the ZVplasty System used in orthopedic and spinal procedures due to potential inadequate sterilization. Patients who received recalled devices should contact their healthcare provider.
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 Class II recall of surgical devices with potential for infection due to inadequate sterilization. Although no illnesses or injuries have been reported, the product poses a risk of harm in invasive surgical procedures, meeting the criteria for High severity.
Plain-English summary
Zavation is recalling 24 units of the ZVplasty System, 20mm (Part# VCF-1020-2), used in orthopedic and spinal procedures. The affected units may not have been adequately sterilized despite being distributed as sterile products.
Inadequate sterilization of medical devices used in surgical procedures creates a potential risk of infection. The affected lot numbers are 13650ZV, 13518ZV, 11677ZV, 11678ZV, and 10514ZV.
These devices were distributed nationwide throughout the United States. Patients who may have received one of the recalled devices should contact their healthcare provider or the manufacturer for guidance on whether follow-up evaluation or corrective action is needed.
The recalled product
- Product
- ZVplasty System, 20mm, Part# VCF-1020-2. For use in Orthopedic / spinal procedures.
- Manufacturer
- Zavation
- Hazard
- inadequate-sterilization
- infection-risk
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 (5)
- Lot Numbers: 13650ZV
- 13518ZV
- 11677ZV
- 11678ZV
- 10514ZV
Distribution
Distributed nationwide across the United States.
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