FDAMarch 25, 2021device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Products distributed as sterile may not have been adequately sterilized
What to do
FDA enforcement status: Terminated
Brands named
zavation
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDA10 GAUGE CEMENT DELIVERY CANNULA, INTVM-CDC. For use in Orthopedic / spinal procedures.2021-03-25
- FDAZVplasty Direct Bipedicular Bone Access Kit with Drill, 10 Gauge, VCF-DDBAK. For use in Orthopedic / spinal procedures.2021-03-25
- FDA11G DIRECT SINGLE - DELIVERY (4 FILLERS-4 SYRINGES) CODE: INTVMN-SCDK. For use in Orthopedic / spinal procedures.2021-03-25
- FDA10 GAUGE CEMENT DELIVERY CANNULA, CODE: INTVM-CDC. For use in Orthopedic / spinal procedures.2021-03-25
- FDA10G DIRECT SINGLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.2021-03-25
- FDAZVplasty, Direct Bipedicular, Bone Access Kit with Coxaial Cannula, REF VCF-DDSKbd. For use in Orthopedic / spinal procedures.2021-03-25
- FDAZVplasty Unipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCG-SCDK. For use in Orthopedic / spinal procedures.2021-03-25
- FDA10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), INTVM-DSSKBD. For use in Orthopedic / spinal procedures.2021-03-25
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