Home › Zavation LLC › Zavation
Zavation
Zavation LLC · Model VCF-1010-2A-LV-XDX · UDI-DI 00842166145993
10
510(k) clearances
4,809
Adverse events (94 deaths)
86
Recalls
114
Facilities
Description
ZVplasty System Assembly
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-12-15 | TEKNIMED SAS | Incorrect expiry date. Product is labeled with expiry date 2027-02-28. The correct expiration date is 2025-02-28. |
| 2021-05-18 | Stryker Spine | The products experienced a 12-hour excursion from the required refrigerated temperature conditions at the distribution center prior to distribution. |
| 2021-05-18 | Stryker Spine | The products experienced a 12-hour excursion from the required refrigerated temperature conditions at the distribution center prior to distribution. |
| 2021-03-25 | Zavation | Products distributed as sterile may not have been adequately sterilized |
| 2021-03-25 | Zavation | Products distributed as sterile may not have been adequately sterilized |
| 2021-03-25 | Zavation | Products distributed as sterile may not have been adequately sterilized |
| 2021-03-25 | Zavation | Products distributed as sterile may not have been adequately sterilized |
| 2021-03-25 | Zavation | Products distributed as sterile may not have been adequately sterilized |
| 2021-03-25 | Zavation | Products distributed as sterile may not have been adequately sterilized |
| 2021-03-25 | Zavation | Products distributed as sterile may not have been adequately sterilized |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.