Z-1762-2021Class II

ZVplasty System, 15mm, Part Numbers: a) VCF-1015-2 b) VCF-1015-2A. For use in Orthopedic / spinal procedures

Name: Z-1762-2021 ZVplasty System, 15mm, Part Numbers: a) VCF-1015-2 b) VCF-1015-2A. For use in Orthopedic / spinal procedures
Creator: Zavation
Published: 2021-03-25
License: https://open.fda.gov/license/

Zavation / initiated 2021-03-25 / Terminated / root cause: supplier

FDA source

Zavation began a recall of ZVplasty System, 15mm, Part Numbers: a) VCF-1015-2 b) VCF-1015-2A. For use in Orthopedic / spinal procedures on 2021-03-25. FDA classified it as Class II and gives the reason as "Products distributed as sterile may not have been adequately sterilized". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-1762-2021
Classification: Class II
Status: Terminated
Initiated: 2021-03-25
Posted: 2021-06-01
Terminated: 2023-03-20
Recalling firm: Zavation
Product: ZVplasty System, 15mm, Part Numbers: a) VCF-1015-2 b) VCF-1015-2A. For use in Orthopedic / spinal procedures.
Product code: NDN Cement, Bone, Vertebroplasty
Reason for recall: Products distributed as sterile may not have been adequately sterilized
Root cause tag: supplier
FDA root cause: Vendor change control
Action: Zavation initially notified their consignees of the problem by email beginning on 03/24/2021 and requested they quarantine the product. The firm sent a subsequent email beginning on 04/13/2021 requesting the return of the product. The recall is being conducted to the user level.
Quantity in commerce: 195 units
Distribution: US nationwide distribution.
Product codes and lots: a) VCF-1015-2, Lot Numbers: 13814ZV, 10950ZV, 11694ZV, 10953ZV, 10779ZV, 10588ZV, 13664ZV, 13469ZV, 13519ZV, 10825ZV, 13885ZV, 12989ZV, 10933ZV, 13758ZV, 14107ZV, 14206ZV, 14680ZV, 14022ZV, 11603ZV, 10505ZV b) VCF-1015-2A, Lot Numbers: 10515ZV, 14197ZV, 14114ZV, 14113ZV, 14024ZV, 14023ZV, 13641ZV, 13471ZV, 13325ZV

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1762-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1700-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01
Z-1701-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01
Z-1702-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01
Z-1703-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01
Z-1704-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01
Z-1705-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01
Z-1706-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01
Z-1707-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01
Z-1708-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01
Z-1709-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01
Z-1710-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01
Z-1711-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01
Z-1712-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01
Z-1713-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01
Z-1714-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01
Z-1715-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01
Z-1716-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01
Z-1717-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01
Z-1718-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01
Z-1719-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01
Z-1720-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01
Z-1721-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01
Z-1722-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01
Z-1723-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01
Z-1724-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01
Z-1725-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01
Z-1726-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01
Z-1727-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01
Z-1728-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01
Z-1729-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01
Z-1730-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01
Z-1731-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01
Z-1732-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01
Z-1733-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01
Z-1734-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01
Z-1735-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01
Z-1736-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01
Z-1737-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01
Z-1738-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01
Z-1739-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01
Z-1740-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01
Z-1741-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01
Z-1742-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01
Z-1743-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01
Z-1744-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01
Z-1745-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01
Z-1746-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01
Z-1747-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01
Z-1748-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01
Z-1749-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01
Z-1750-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01
Z-1751-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01
Z-1752-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01
Z-1753-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01
Z-1754-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01
Z-1755-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01
Z-1756-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01
Z-1757-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01
Z-1758-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01
Z-1759-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01
Z-1760-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01
Z-1761-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01
Z-1762-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01
Z-1763-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01
Z-1764-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01
Z-1765-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01
Z-1766-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01
Z-1767-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01
Z-1768-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01
Z-1769-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01
Z-1770-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01

Product code NDN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)