Device recall: 10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), INTVM-DSSKBD. For use in Orthopedic / spinal procedures.
Class II FDA enforcement event 87661. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Products distributed as sterile may not have been adequately sterilized
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Zavation started this device recall on 25 Mar 2021. The firm address in the FDA record is in Flowood, MS. FDA put the recall in Class II. FDA event 87661 has 71 product records. The first FDA enforcement report date is 9 Jun 2021. The record gives the status Terminated, with the termination date 20 Mar 2023.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
US nationwide distribution.
Recalling firm
Zavation, Flowood, MS.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
71 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1700-2021 | 10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), INTVM-DSSKBD. For use in Orthopedic / spinal procedures. | 56 units | Class II | Terminated | 9 Jun 2021 |
| Z-1701-2021 | 10 GAUGE CEMENT DELIVERY CANNULA, INTVM-CDC. For use in Orthopedic / spinal procedures. | 130 units | Class II | Terminated | 9 Jun 2021 |
| Z-1702-2021 | ZVplasty Drill, 10 Gauge, REF VCF-1006. For use in Orthopedic / spinal procedures. | 38 units | Class II | Terminated | 9 Jun 2021 |
| Z-1703-2021 | ZVplasty Direct Access Beveled Tip Trocar, 10 Gauge, REF VCF-1022. For use in Orthopedic / spinal procedures. | 335 units | Class II | Terminated | 9 Jun 2021 |
| Z-1704-2021 | ZVplasty Direct Access Diamond Tip Trocar, 10 Gauge, REF VCF-1023. For use in Orthopedic / spinal procedures. | 88 units | Class II | Terminated | 9 Jun 2021 |
| Z-1705-2021 | ZVplasty, Bipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCF-DCDK. For use in Orthopedic / spinal procedures. | 14 units | Class II | Terminated | 9 Jun 2021 |
| Z-1706-2021 | ZVplasty Direct Bipedicular Bone Access Kit with Drill, 10 Gauge, VCF-DDBAK. For use in Orthopedic / spinal procedures. | Class II | Terminated | 9 Jun 2021 | |
| Z-1707-2021 | ZVplasty, Direct Bipedicular, Bone Access Kit with Coxaial Cannula, REF VCF-DDSKbd. For use in Orthopedic / spinal procedures. | 2 units | Class II | Terminated | 9 Jun 2021 |
| Z-1708-2021 | ZVplasty Direct Unipedicular Bone Access Kit with Drill, 10 Gauge, REF VCF-DSBAK. For use in Orthopedic / spinal procedures. | 11 units | Class II | Terminated | 9 Jun 2021 |
| Z-1709-2021 | ZVplasty Unipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCG-SCDK. For use in Orthopedic / spinal procedures. | 72 units | Class II | Terminated | 9 Jun 2021 |
| Z-1710-2021 | ZVplasty Bipedicular Cement Delivery Cannula, 11 Gauge, REF VCF-DCDK-11. For use in Orthopedic / spinal procedures. | 1 unit | Class II | Terminated | 9 Jun 2021 |
| Z-1711-2021 | ZVplasty Direct Access Bevel Tip Trocar, 11 Gauge, REF VCF-1022-11. For use in Orthopedic / spinal procedures. | 98 units | Class II | Terminated | 9 Jun 2021 |
| Z-1712-2021 | ZVplasty Direct Access Diamond Tip Trocar, 11 Gauge, REF VCF-1023-11. For use in Orthopedic / spinal procedures. | 113 units | Class II | Terminated | 9 Jun 2021 |
| Z-1713-2021 | ZVplasty Direct Bipedicular Bone Access Kit with Drill, 11 Gauge, REF VCF-DDBAK-11. For use in Orthopedic / spinal procedures. | 15 units | Class II | Terminated | 9 Jun 2021 |
| Z-1714-2021 | 10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), CODE INTVM-DSSKbd. For use in Orthopedic / spinal procedures. | 56 units | Class II | Terminated | 9 Jun 2021 |
| Z-1715-2021 | 10G DIRECT SINGLE - ACCESS, CODE INTVM-DSBAK. For use in Orthopedic / spinal procedures. | 2 units | Class II | Terminated | 9 Jun 2021 |
| Z-1716-2021 | 10 GAUGE DIRECT ACCESS DIAMOND TIP, CODE: INTVM-DWCd. For use in Orthopedic / spinal procedures. | 89 units | Class II | Terminated | 9 Jun 2021 |
| Z-1717-2021 | 11G DIRECT SINGLE - DELIVERY (4 FILLERS-4 SYRINGES) CODE: INTVMN-SCDK. For use in Orthopedic / spinal procedures. | 7 units | Class II | Terminated | 9 Jun 2021 |
| Z-1718-2021 | 10 GAUGE CEMENT DELIVERY CANNULA, CODE: INTVM-CDC. For use in Orthopedic / spinal procedures. | 130 units | Class II | Terminated | 9 Jun 2021 |
| Z-1719-2021 | 11G DIRECT WORKING CANNULA DIAMOND TIP MINI, CODE: INTVMN-DWCD. For use in Orthopedic / spinal procedures. | 58 units | Class II | Terminated | 9 Jun 2021 |
| Z-1720-2021 | 10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES, CODE: INTVM-SCDK. For use in Orthopedic / spinal procedures. | 122 units | Class II | Terminated | 9 Jun 2021 |
| Z-1721-2021 | ZVplasty Unipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCF-SCDK. For use in Orthopedic / spinal procedures. | 72 units | Class II | Terminated | 9 Jun 2021 |
| Z-1722-2021 | ZVplasty Biopsy Device, 10 Gauge, REF VCF-1010. For use in Orthopedic / spinal procedures. | 162 units | Class II | Terminated | 9 Jun 2021 |
| Z-1723-2021 | ZVplasty Biopsy Device, 11 Gauge, REF VCF-1010-11. For use in Orthopedic / spinal procedures. | 34 units | Class II | Terminated | 9 Jun 2021 |
| Z-1724-2021 | ZVplasty Direct Access Bevel Tip Trocar, 11 Gauge, REF VCF-1022-11. For use in Orthopedic / spinal procedures. | 98 units | Class II | Terminated | 9 Jun 2021 |
| Z-1725-2021 | ZVplasty Directional Cement Cannula Long, REF VCF-1080-L. For use in Orthopedic / spinal procedures. | 27 units | Class II | Terminated | 9 Jun 2021 |
| Z-1726-2021 | ZVplasty Directional Cement Cannula (4 pieces per pack), REF VCF-1080-S4. For use in Orthopedic / spinal procedures. | 11 units | Class II | Terminated | 9 Jun 2021 |
| Z-1727-2021 | 10G DIRECT SINGLE - ACCESS, CODE: INTV-DWCb. For use in Orthopedic / spinal procedures. | 24 units | Class II | Terminated | 9 Jun 2021 |
| Z-1728-2021 | ZVplasty Direct Access Diamond Tip Trocar, 11 Gauge, REF VCF-1023-11. For use in Orthopedic / spinal procedures. | 113 units | Class II | Terminated | 9 Jun 2021 |
| Z-1729-2021 | ZVplasty Direct Bipedicular Bone Access Kit with Drill, 11 Gauge, REF VCF-DDBAK-11. For use in Orthopedic / spinal procedures. | 15 units | Class II | Terminated | 9 Jun 2021 |
| Z-1730-2021 | 10 G Coxaxial Cannula with Tuohy Connection, CODE: INTVM-CC. For use in Orthopedic / spinal procedures. | 10 units | Class II | Terminated | 9 Jun 2021 |
| Z-1731-2021 | 10 Gauge Drill, CODE: INTVM-DRL. For use in Orthopedic / spinal procedures. | 58 units | Class II | Terminated | 9 Jun 2021 |
| Z-1732-2021 | ZVplasty Cement Delivery Cannula, REF VCF-1007. For use in Orthopedic / spinal procedures. | 22 units | Class II | Terminated | 9 Jun 2021 |
| Z-1733-2021 | 10G BEVELED TROCAR/CANNULA. For use in Orthopedic / spinal procedures. | Class II | Terminated | 9 Jun 2021 | |
| Z-1734-2021 | 10G DIRECT SINGLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures. | Class II | Terminated | 9 Jun 2021 | |
| Z-1735-2021 | 10G SINGLE CEMENT DELIVERY KIT (5 FILLERS). For use in Orthopedic / spinal procedures. | Class II | Terminated | 9 Jun 2021 | |
| Z-1736-2021 | 11G BEVELED TROCAR/CANNULA. For use in Orthopedic / spinal procedures. | Class II | Terminated | 9 Jun 2021 | |
| Z-1737-2021 | 11G DIAMOND TROCAR/CANNULA. For use in Orthopedic / spinal procedures. | Class II | Terminated | 9 Jun 2021 | |
| Z-1738-2021 | 10G DIRECT DOUBLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures. | Class II | Terminated | 9 Jun 2021 | |
| Z-1739-2021 | 11G DIRECT DOUBLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures. | Class II | Terminated | 9 Jun 2021 | |
| Z-1740-2021 | 10G SINGLE CEMENT DELIVERY KIT (5 FILLERS). For use in Orthopedic / spinal procedures. | Class II | Terminated | 9 Jun 2021 | |
| Z-1741-2021 | 10G DOUBLE CEMENT DELIVERY KIT (8 FILLERS). For use in Orthopedic / spinal procedures. | Class II | Terminated | 9 Jun 2021 | |
| Z-1742-2021 | 10G DIRECT DOUBLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures. | Class II | Terminated | 9 Jun 2021 | |
| Z-1743-2021 | 10G DIRECT SINGLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures. | Class II | Terminated | 9 Jun 2021 | |
| Z-1744-2021 | 10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES STERILE. For use in Orthopedic / spinal procedures. | Class II | Terminated | 9 Jun 2021 | |
| Z-1745-2021 | 10G COAXIAL CANNULA WITH TUOHY CONNECTION STERILE. For use in Orthopedic / spinal procedures. | Class II | Terminated | 9 Jun 2021 | |
| Z-1746-2021 | 10 GAUGE DRILL STERILE. For use in Orthopedic / spinal procedures. | Class II | Terminated | 9 Jun 2021 | |
| Z-1747-2021 | 10G CEMENT DELIVERY CANNULA. For use in Orthopedic / spinal procedures. | Class II | Terminated | 9 Jun 2021 | |
| Z-1748-2021 | 10G BEVELED TROCAR/CANNULA. For use in Orthopedic / spinal procedures. | Class II | Terminated | 9 Jun 2021 | |
| Z-1749-2021 | 10 GAUGE DIRECT UNILATERAL STYLET (1 X DIAMOND 1 X BEVEL) STERILE. For use in Orthopedic / spinal procedures. | Class II | Terminated | 9 Jun 2021 | |
| Z-1750-2021 | CEMIX - CEMENT MIXING SYSTEM STERILE, CODE INTV-MMS. For use in Orthopedic / spinal procedures. | 197 | Class II | Terminated | 9 Jun 2021 |
| Z-1751-2021 | InterV, 10G Kyphoplasty Kits, REF numbers: a) INTVM-10-DSK b) INTVM-10-SBK c) INTVM-15-DSK d) INTVM-15-DSKC e) INTVM-15-SBK f) INTVM-15-SIKBC g) INTVM-20-DSK h) INTVM-20-SBK. For use in Orthopedic / spinal procedures. | 503 units | Class II | Terminated | 9 Jun 2021 |
| Z-1752-2021 | InterV, 10G FLEX Kyphoplasty, REF Number: a) INTVM-15-FLDSK b) INTVM-20-FLDSK. For use in Orthopedic / spinal procedures. | 178 units | Class II | Terminated | 9 Jun 2021 |
| Z-1753-2021 | InterV CurvePlus Kit, REF Numbers: a) INTVMC-15-FLDSK b) INTVMC-20-FLDSK. For use in Orthopedic / spinal procedures. | 36 units | Class II | Terminated | 9 Jun 2021 |
| Z-1754-2021 | InterV 10G Bone Access Tools/Kit, REF INTVM-FLNK. For use in Orthopedic / spinal procedures. | 3 units | Class II | Terminated | 9 Jun 2021 |
| Z-1755-2021 | InterV 11G Kyphoplasty Kit, REF Numbers: a) INTVMN-10-DSK b) INTVMN-15-DSK c) INTVMN-15-DSKC d) INTVMN-20-DSK. For use in Orthopedic / spinal procedures. | 119 units | Class II | Terminated | 9 Jun 2021 |
| Z-1756-2021 | OsteoFlex BONE CEMENT, REF Numbers: a) INTV-OSFL b) INTV-OSFL-LV. For use in Orthopedic / spinal procedures. | 200 units | Class II | Terminated | 9 Jun 2021 |
| Z-1757-2021 | ZVplasty System, 10mm, Pat# VCF-1010-2. For use in Orthopedic / spinal procedures. | 31 units | Class II | Terminated | 9 Jun 2021 |
| Z-1758-2021 | ZVplasty, 10G, 10mm Double Balloon Kit, REF VCF-1010-DBK. For use in Orthopedic / spinal procedures. | 7 units | Class II | Terminated | 9 Jun 2021 |
| Z-1759-2021 | ZVplasty System, 15mm, Part# VCF-1015-1. For use in Orthopedic / spinal procedures. | 516 units | Class II | Terminated | 9 Jun 2021 |
The table shows 60 of 71 product records. The FDA enforcement report lists all the records.
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2021
- 900
- Share of these events in Class II
- 89%
- Product records in this event
- 71
- Events of the firm on the register
- 1
Official channels
- FDA enforcement report Z-1700-2021The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 87661. https://recallregister.com/fda/ii/87661/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
US nationwide distribution.
- What quantity of product is in FDA event 87661?
- The event has 71 product records. The first record gives this quantity:
56 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2021 have the same class?
- 89% of the 900 device events that started in 2021 are in Class II.