Flowood, MS, United States
Zavation recalls
1 recall recorded since 2018, most recently on 25 March 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 25 March 2021
- Terminated
- 20 March 2023
- Reason
- Products distributed as sterile may not have been adequately sterilized
- Distribution
- US nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1738-2021, Z-1760-2021, Z-1721-2021, Z-1740-2021, Z-1757-2021, Z-1726-2021, Z-1759-2021, Z-1717-2021, Z-1731-2021, Z-1720-2021, Z-1762-2021, Z-1737-2021 and 59 more
- 10G DIRECT DOUBLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.
- ZVplasty System, 15mm, Part# VCF-1015-1. For use in Orthopedic / spinal procedures.
- ZVplasty Unipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCF-SCDK. For use in Orthopedic / spinal procedures.
- 10G SINGLE CEMENT DELIVERY KIT (5 FILLERS). For use in Orthopedic / spinal procedures.
- ZVplasty System, 10mm, Pat# VCF-1010-2. For use in Orthopedic / spinal procedures.
- ZVplasty Directional Cement Cannula (4 pieces per pack), REF VCF-1080-S4. For use in Orthopedic / spinal procedures.
- ZVplasty System, 15mm, Part# VCF-1015-1. For use in Orthopedic / spinal procedures.
- 11G DIRECT SINGLE - DELIVERY (4 FILLERS-4 SYRINGES) CODE: INTVMN-SCDK. For use in Orthopedic / spinal procedures.
- and 63 more product lines
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.