VERTEBREX SINGLE BALLOON KIT, REF VBRX-15-SBK-10. For use in Orthopedic / spinal procedures.
Reported: June 9, 2021 Initiated: March 25, 2021 #Z-1769-2021
Product Description
VERTEBREX SINGLE BALLOON KIT, REF VBRX-15-SBK-10. For use in Orthopedic / spinal procedures.
Reason for Recall
Products distributed as sterile may not have been adequately sterilized
Details
- Recalling Firm
- Zavation
- Units Affected
- 140 units
- Distribution
- US nationwide distribution.
- Location
- Flowood, MS
Frequently Asked Questions
What product was recalled? ▼
VERTEBREX SINGLE BALLOON KIT, REF VBRX-15-SBK-10. For use in Orthopedic / spinal procedures.. Recalled by Zavation. Units affected: 140 units.
Why was this product recalled? ▼
Products distributed as sterile may not have been adequately sterilized
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 9, 2021. Severity: Moderate. Recall number: Z-1769-2021.
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