FDA Medical Device Recalls (openFDA)
Zavation: OsteoFlex Cement and Mixing System, REF VCF-OSFL. For use in Orthopedic / spinal procedures.
- Recall number
- Z-1768-2021
- Recalling firm
- Zavation
- Product
- OsteoFlex Cement and Mixing System, REF VCF-OSFL. For use in Orthopedic / spinal procedures.
- Status
- Terminated
- Initiated
- 2021-03-25
- Posted
- not on file
- Terminated
- 2023-03-20
- Reason
- Products distributed as sterile may not have been adequately sterilized
- 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
- 846 units
- Distribution
- US nationwide distribution.
- Lot, serial or model codes
- Lot Numbers: 13844ZV, 12320ZV, 14359ZV, 14171ZV, 13887ZV, 12670ZV, 11759ZV, 11850ZV, 13750ZV, 14273ZV, 14017ZV, 13665ZV, 12766ZV, 12037ZV, 14100ZV, 11693ZV, 14472ZV, 14388ZV, 13651ZV, 13876ZV
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NDN
- Firm FEI
- 3008583793
- Firm city
- Flowood
- Firm state
- MS
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28