Orthopedic Drill Kit Recalled for Potential Sterilization Failure
Zavation is recalling the ZVplasty Direct Bipedicular Bone Access Kit due to products potentially lacking adequate sterilization. The 15 units affected (Lot 20071774, 19123262) were distributed nationwide.
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 medical device recall involving surgical instruments. The hazard—inadequate sterilization—represents a risk-of-harm to patients from infection, with no illnesses or injuries reported to date. Per the severity rubric, risk-of-harm products where injury has not yet been reported are scored as High (3).
Plain-English summary
Zavation has recalled the ZVplasty Direct Bipedicular Bone Access Kit with Drill, 11 Gauge (REF VCF-DDBAK-11), a surgical instrument used in orthopedic and spinal procedures. Fifteen units with lot numbers 20071774 and 19123262 were distributed nationwide across the United States. The recall was initiated because products were distributed with claims of sterility but may not have been adequately sterilized.
Use of inadequately sterilized surgical instruments in invasive orthopedic and spinal procedures poses a risk of infection to patients. If you have received or used one of the affected units, contact Zavation immediately for instructions on returning the product or obtaining a replacement.
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: 20071774
- 19123262
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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