ZVplasty 10G FLEX Kyphoplasty Spinal Device Recall Due to Sterilization Failure
Zavation is recalling 19 units of ZVplasty 10G FLEX KYPHOPLASTY spinal devices because distributed units may not have been adequately sterilized, posing infection risk to patients.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 for inadequate sterilization of a surgical implant device. Although the potential for harm from infection is serious, no illnesses or injuries have been reported, placing this at High severity under the criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Zavation is recalling 19 units of the ZVplasty 10G FLEX KYPHOPLASTY spinal device (model VCF-1015-FLEX) distributed nationwide in the United States. The affected lot numbers are 14522ZV, 12260ZV, 12896ZV, and 11557ZV.
The device is used in orthopedic and spinal procedures, including kyphoplasty (a minimally invasive procedure to treat vertebral compression fractures). Zavation initiated this recall because some units distributed as sterile may not have been adequately sterilized.
Inadequate sterilization of surgical implants poses a risk of infection. Any patient who received this device should consult their healthcare provider immediately if they experience signs of infection such as fever, persistent pain, or unusual wound drainage. Healthcare providers who have used these devices should review patient records and monitor recipients for infection-related complications.
The recalled product
- Product
- ZVplasty 10G, FLEX KYPHOPLASTY, REF VCF-1015-FLEX. For use in Orthopedic / spinal procedures.
- Manufacturer
- Zavation
- Affected units
- 19
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 (4)
- Lot Numbers: 14522ZV
- 12260ZV
- 12896ZV
- 11557ZV
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.
See all 71 products in this recall →Related recalls
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