Z-1747-2021Class II
10G CEMENT DELIVERY CANNULA. For use in Orthopedic / spinal procedures
Zavation / initiated 2021-03-25 / Terminated / root cause: supplier
Zavation began a recall of 10G CEMENT DELIVERY CANNULA. For use in Orthopedic / spinal procedures on . FDA classified it as Class II and gives the reason as "Products distributed as sterile may not have been adequately sterilized". As of , the recall status on record is Terminated, and MDM tags the root cause as supplier.
Recall record
- Recall number
- Z-1747-2021
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Zavation
- Product
- 10G CEMENT DELIVERY CANNULA. 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.
- Distribution
- US nationwide distribution.
- Product codes and lots
- Pending
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1700-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1701-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1702-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1703-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1704-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1705-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1706-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1707-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1708-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1709-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1710-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1711-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1712-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1713-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1714-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1715-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1716-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1717-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1718-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1719-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1720-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1721-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1722-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1723-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1724-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1725-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1726-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1727-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1728-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1729-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1730-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1731-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1732-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1733-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1734-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1735-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1736-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1737-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1738-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1739-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1740-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1741-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1742-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1743-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1744-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1745-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1746-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1747-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1748-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1749-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1750-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1751-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1752-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1753-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1754-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1755-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1756-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1757-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1758-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1759-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1760-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1761-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1762-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1763-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1764-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1765-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1766-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1767-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1768-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1769-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1770-2021 | Class II | Terminated | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.