Spinal surgery implant kit recalled for inadequate sterilization
Zavation is recalling ZVplasty 10G spinal implant kits that may not have been properly sterilized. The affected devices were distributed nationwide and may pose infection risk if implanted.
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 medical device intended for invasive spinal procedures where sterility is critical to patient safety. No illnesses or injuries have been reported, but inadequate sterilization poses a direct risk of serious infection.
Plain-English summary
Zavation has recalled the ZVplasty 10G, 15mm, Additional Level Kit (REF VCF-1015-1A) used in orthopedic spinal procedures. The products distributed as sterile may not have been adequately sterilized.
The recall covers lot number 12302ZV, representing 3 units distributed nationwide in the United States. Implantation of inadequately sterilized surgical devices poses a risk of infection.
Patients and healthcare providers who have this device should be aware of the sterilization issue and consult appropriate resources for guidance on next steps.
The recalled product
- Product
- ZVplasty 10G, 15mm, Additional Level Kit, REF VCF-1015-1A. For use in Orthopedic / spinal procedures.
- Manufacturer
- Zavation
- Affected units
- 3
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 Numbers: 12302ZV
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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