Zavation surgical bone access kit recalled due to inadequate sterilization
Zavation is recalling ZVplasty Direct Bipedicular Bone Access Kits because products distributed as sterile may not have been adequately sterilized. Patients who received these devices should contact their healthcare provider.
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 a Class II medical device recall involving inadequate sterilization, creating a risk of harm. No illnesses or injuries have been reported. Per the rubric, risk-of-harm products without reported injury score as High (3).
Plain-English summary
Zavation is recalling the ZVplasty Direct Bipedicular Bone Access Kit with Drill (11 Gauge, REF VCF-DDBAK-11), which is used in orthopedic and spinal procedures. The recall affects 15 units distributed nationwide in the United States.
The recalled product was distributed as sterile but may not have been adequately sterilized. This creates a potential risk for patients who received these devices.
Patients who underwent spinal or orthopedic procedures using this product should contact their healthcare provider. Healthcare facilities that received the affected product lots (19123262, 20071774) should discontinue use and identify any patients who may have received these devices.
The recalled product
- Product
- ZVplasty Direct Bipedicular Bone Access Kit with Drill, 11 Gauge, REF VCF-DDBAK-11. For use in Orthopedic / spinal procedures.
- Manufacturer
- Zavation
- Affected units
- 15
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: 19123262
- 20071774
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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