Zavation

Complete recall history across all FDA and CPSC categories — 71 total recalls

Zavation appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (71)

FDA medical device enforcement actions by Zavation. Showing most recent 50.

Date Product Reason Class
Mar 25, 2021 ZVplasty Biopsy Device, 11 Gauge, REF VCF-1010-11. For use in Orthopedic / s... Products distributed as sterile may not have been adequately sterilized Class II
Mar 25, 2021 ZVplasty, Direct Bipedicular, Bone Access Kit with Coxaial Cannula, REF VCF-D... Products distributed as sterile may not have been adequately sterilized Class II
Mar 25, 2021 ZVplasty Cement Delivery Cannula, REF VCF-1007. For use in Orthopedic / spin... Products distributed as sterile may not have been adequately sterilized Class II
Mar 25, 2021 CEMIX - CEMENT MIXING SYSTEM STERILE, CODE INTV-MMS. For use in Orthopedic /... Products distributed as sterile may not have been adequately sterilized Class II
Mar 25, 2021 10G BEVELED TROCAR/CANNULA. For use in Orthopedic / spinal procedures. Products distributed as sterile may not have been adequately sterilized Class II
Mar 25, 2021 10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), CODE INTVM-DSSKbd. ... Products distributed as sterile may not have been adequately sterilized Class II
Mar 25, 2021 10 G Coxaxial Cannula with Tuohy Connection, CODE: INTVM-CC. For use in Orth... Products distributed as sterile may not have been adequately sterilized Class II
Mar 25, 2021 ZVplasty Direct Bipedicular Bone Access Kit with Drill, 11 Gauge, REF VCF-DDB... Products distributed as sterile may not have been adequately sterilized Class II
Mar 25, 2021 InterV 10G Bone Access Tools/Kit, REF INTVM-FLNK. For use in Orthopedic / sp... Products distributed as sterile may not have been adequately sterilized Class II
Mar 25, 2021 11G DIRECT DOUBLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures. Products distributed as sterile may not have been adequately sterilized Class II
Mar 25, 2021 10G COAXIAL CANNULA WITH TUOHY CONNECTION STERILE. For use in Orthopedic / s... Products distributed as sterile may not have been adequately sterilized Class II
Mar 25, 2021 OsteoFlex Cement and Mixing System, REF VCF-OSFL. For use in Orthopedic / sp... Products distributed as sterile may not have been adequately sterilized Class II
Mar 25, 2021 InterV, 10G Kyphoplasty Kits, REF numbers: a) INTVM-10-DSK b) INTVM-10-SBK ... Products distributed as sterile may not have been adequately sterilized Class II
Mar 25, 2021 ZVplasty System, 20mm, Part# VCF-1020-2. For use in Orthopedic / spinal proc... Products distributed as sterile may not have been adequately sterilized Class II
Mar 25, 2021 10 GAUGE DIRECT ACCESS DIAMOND TIP, CODE: INTVM-DWCd. For use in Orthopedic ... Products distributed as sterile may not have been adequately sterilized Class II
Mar 25, 2021 ZVplasty Direct Access Diamond Tip Trocar, 10 Gauge, REF VCF-1023. For use i... Products distributed as sterile may not have been adequately sterilized Class II
Mar 25, 2021 10 GAUGE DIRECT UNILATERAL STYLET (1 X DIAMOND 1 X BEVEL) STERILE. For use i... Products distributed as sterile may not have been adequately sterilized Class II
Mar 25, 2021 ZVplasty Direct Access Bevel Tip Trocar, 11 Gauge, REF VCF-1022-11. For use ... Products distributed as sterile may not have been adequately sterilized Class II
Mar 25, 2021 ZVplasty Direct Unipedicular Bone Access Kit with Drill, 10 Gauge, REF VCF-DS... Products distributed as sterile may not have been adequately sterilized Class II
Mar 25, 2021 ZVplasty 10G, 20mm, Traditional Unipedicular Kit, REF VCF-1020-1. For use in... Products distributed as sterile may not have been adequately sterilized Class II
Mar 25, 2021 10G DIRECT SINGLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures. Products distributed as sterile may not have been adequately sterilized Class II
Mar 25, 2021 ZVplasty 10G, 15mm Single Balloon Kit, REF VCF-SBK. For use in Orthopedic / ... Products distributed as sterile may not have been adequately sterilized Class II
Mar 25, 2021 OsteoFlex BONE CEMENT, REF Numbers: a) INTV-OSFL b) INTV-OSFL-LV. For us... Products distributed as sterile may not have been adequately sterilized Class II
Mar 25, 2021 VERTEBREX SINGLE BALLOON KIT, REF VBRX-20-SBK-10. For use in Orthopedic / sp... Products distributed as sterile may not have been adequately sterilized Class II
Mar 25, 2021 ZVPlasty, 11G, 15mm Traditional Bipedicular Kit, REF VCF-1115-2. For use in ... Products distributed as sterile may not have been adequately sterilized Class II
Mar 25, 2021 ZVplasty Direct Access Diamond Tip Trocar, 11 Gauge, REF VCF-1023-11. For us... Products distributed as sterile may not have been adequately sterilized Class II
Mar 25, 2021 10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), INTVM-DSSKBD. For ... Products distributed as sterile may not have been adequately sterilized Class II
Mar 25, 2021 ZVplasty 10G, 15mm, Additional Level Kit, REF VCF-1015-1A. For use in Orthop... Products distributed as sterile may not have been adequately sterilized Class II
Mar 25, 2021 ZVplasty, Bipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCF-DCDK. F... Products distributed as sterile may not have been adequately sterilized Class II
Mar 25, 2021 10G DIRECT SINGLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures. Products distributed as sterile may not have been adequately sterilized Class II
Mar 25, 2021 ZVplasty Unipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCG-SCDK. F... Products distributed as sterile may not have been adequately sterilized Class II
Mar 25, 2021 10 GAUGE CEMENT DELIVERY CANNULA, INTVM-CDC. For use in Orthopedic / spinal ... Products distributed as sterile may not have been adequately sterilized Class II
Mar 25, 2021 ZVplasty 10G, FLEX KYPHOPLASTY, REF VCF-1015-FLEX. For use in Orthopedic / s... Products distributed as sterile may not have been adequately sterilized Class II
Mar 25, 2021 ZVplasty Biopsy Device, 10 Gauge, REF VCF-1010. For use in Orthopedic / spin... Products distributed as sterile may not have been adequately sterilized Class II
Mar 25, 2021 10G DIRECT SINGLE - ACCESS, CODE INTVM-DSBAK. For use in Orthopedic / spinal... Products distributed as sterile may not have been adequately sterilized Class II
Mar 25, 2021 10G SINGLE CEMENT DELIVERY KIT (5 FILLERS). For use in Orthopedic / spina... Products distributed as sterile may not have been adequately sterilized Class II
Mar 25, 2021 ZVplasty Direct Bipedicular Bone Access Kit with Drill, 11 Gauge, REF VCF-DDB... Products distributed as sterile may not have been adequately sterilized Class II
Mar 25, 2021 10G BEVELED TROCAR/CANNULA. For use in Orthopedic / spinal procedures. Products distributed as sterile may not have been adequately sterilized Class II
Mar 25, 2021 10 GAUGE DRILL STERILE. For use in Orthopedic / spinal procedures. Products distributed as sterile may not have been adequately sterilized Class II
Mar 25, 2021 ZVplasty Directional Cement Cannula Long, REF VCF-1080-L. For use in Orthope... Products distributed as sterile may not have been adequately sterilized Class II
Mar 25, 2021 10 GAUGE CEMENT DELIVERY CANNULA, CODE: INTVM-CDC. For use in Orthopedic / s... Products distributed as sterile may not have been adequately sterilized Class II
Mar 25, 2021 11G DIRECT WORKING CANNULA DIAMOND TIP MINI, CODE: INTVMN-DWCD. For use in O... Products distributed as sterile may not have been adequately sterilized Class II
Mar 25, 2021 ZVplasty Direct Access Bevel Tip Trocar, 11 Gauge, REF VCF-1022-11. For use ... Products distributed as sterile may not have been adequately sterilized Class II
Mar 25, 2021 InterV 11G Kyphoplasty Kit, REF Numbers: a) INTVMN-10-DSK b) INTVMN-15-DSK... Products distributed as sterile may not have been adequately sterilized Class II
Mar 25, 2021 10G DIRECT SINGLE - ACCESS, CODE: INTV-DWCb. For use in Orthopedic / spinal ... Products distributed as sterile may not have been adequately sterilized Class II
Mar 25, 2021 10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES STERILE. For use in Ort... Products distributed as sterile may not have been adequately sterilized Class II
Mar 25, 2021 10G DIRECT DOUBLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures. Products distributed as sterile may not have been adequately sterilized Class II
Mar 25, 2021 VERTEBREX SINGLE BALLOON KIT, REF VBRX-15-SBK-10. For use in Orthopedic / sp... Products distributed as sterile may not have been adequately sterilized Class II
Mar 25, 2021 ZVplasty Direct Access Diamond Tip Trocar, 11 Gauge, REF VCF-1023-11. For us... Products distributed as sterile may not have been adequately sterilized Class II
Mar 25, 2021 ZVplasty Drill, 10 Gauge, REF VCF-1006. For use in Orthopedic / spinal proce... Products distributed as sterile may not have been adequately sterilized Class II

View all 71 device recalls →

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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