510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

Device recalls

Recall records from FDA, newest initiation date first.

Every device recall MDM has ingested. The recall record supplies the product, the reason and the product code; the matching enforcement report supplies the Class I, II or III classification. Where the two have not been joined, the class is left blank rather than assumed.

Data as of , the FDA export date. FDA medical device recall database

59,476 records, page 294 of 1190
FDA device recalls, page 294 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1752-2021Class IIInterV, 10G FLEX Kyphoplasty, REF Number: a) INTVM-15-FLDSK b) INTVM-20-FLDSK. For use...ZavationNDN
Z-1751-2021Class IIInterV, 10G Kyphoplasty Kits, REF numbers: a) INTVM-10-DSK b) INTVM-10-SBK c)...ZavationNDN
Z-1750-2021Class IICEMIX - CEMENT MIXING SYSTEM STERILE, CODE INTV-MMS. For use in Orthopedic / spinal...ZavationNDN
Z-1749-2021Class II10 GAUGE DIRECT UNILATERAL STYLET (1 X DIAMOND 1 X BEVEL) STERILE. For use in Orthopedic...ZavationNDN
Z-1748-2021Class II10G BEVELED TROCAR/CANNULA. For use in Orthopedic / spinal procedures.ZavationNDN
Z-1747-2021Class II10G CEMENT DELIVERY CANNULA. For use in Orthopedic / spinal procedures.ZavationNDN
Z-1746-2021Class II10 GAUGE DRILL STERILE. For use in Orthopedic / spinal procedures.ZavationNDN
Z-1745-2021Class II10G COAXIAL CANNULA WITH TUOHY CONNECTION STERILE. For use in Orthopedic / spinal...ZavationNDN
Z-1744-2021Class II10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES STERILE. For use in Orthopedic /...ZavationNDN
Z-1743-2021Class II10G DIRECT SINGLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.ZavationNDN
Z-1742-2021Class II10G DIRECT DOUBLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.ZavationNDN
Z-1741-2021Class II10G DOUBLE CEMENT DELIVERY KIT (8 FILLERS). For use in Orthopedic / spinal procedures.ZavationNDN
Z-1740-2021Class II10G SINGLE CEMENT DELIVERY KIT (5 FILLERS). For use in Orthopedic / spinal procedures.ZavationNDN
Z-1739-2021Class II11G DIRECT DOUBLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.ZavationNDN
Z-1738-2021Class II10G DIRECT DOUBLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.ZavationNDN
Z-1737-2021Class II11G DIAMOND TROCAR/CANNULA. For use in Orthopedic / spinal procedures.ZavationNDN
Z-1736-2021Class II11G BEVELED TROCAR/CANNULA. For use in Orthopedic / spinal procedures.ZavationNDN
Z-1735-2021Class II10G SINGLE CEMENT DELIVERY KIT (5 FILLERS). For use in Orthopedic / spinal procedures.ZavationNDN
Z-1734-2021Class II10G DIRECT SINGLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.ZavationNDN
Z-1733-2021Class II10G BEVELED TROCAR/CANNULA. For use in Orthopedic / spinal procedures.ZavationNDN
Z-1732-2021Class IIZVplasty Cement Delivery Cannula, REF VCF-1007. For use in Orthopedic / spinal...ZavationNDN
Z-1731-2021Class II10 Gauge Drill, CODE: INTVM-DRL. For use in Orthopedic / spinal procedures.ZavationNDN
Z-1730-2021Class II10 G Coxaxial Cannula with Tuohy Connection, CODE: INTVM-CC. For use in Orthopedic /...ZavationNDN
Z-1729-2021Class IIZVplasty Direct Bipedicular Bone Access Kit with Drill, 11 Gauge, REF VCF-DDBAK-11. For...ZavationNDN
Z-1728-2021Class IIZVplasty Direct Access Diamond Tip Trocar, 11 Gauge, REF VCF-1023-11. For use in...ZavationNDN
Z-1727-2021Class II10G DIRECT SINGLE - ACCESS, CODE: INTV-DWCb. For use in Orthopedic / spinal procedures.ZavationNDN
Z-1726-2021Class IIZVplasty Directional Cement Cannula (4 pieces per pack), REF VCF-1080-S4. For use in...ZavationNDN
Z-1725-2021Class IIZVplasty Directional Cement Cannula Long, REF VCF-1080-L. For use in Orthopedic / spinal...ZavationNDN
Z-1724-2021Class IIZVplasty Direct Access Bevel Tip Trocar, 11 Gauge, REF VCF-1022-11. For use in...ZavationNDN
Z-1723-2021Class IIZVplasty Biopsy Device, 11 Gauge, REF VCF-1010-11. For use in Orthopedic / spinal...ZavationNDN
Z-1722-2021Class IIZVplasty Biopsy Device, 10 Gauge, REF VCF-1010. For use in Orthopedic / spinal...ZavationNDN
Z-1721-2021Class IIZVplasty Unipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCF-SCDK. For use in...ZavationNDN
Z-1720-2021Class II10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES, CODE: INTVM-SCDK. For use in...ZavationNDN
Z-1719-2021Class II11G DIRECT WORKING CANNULA DIAMOND TIP MINI, CODE: INTVMN-DWCD. For use in Orthopedic /...ZavationNDN
Z-1718-2021Class II10 GAUGE CEMENT DELIVERY CANNULA, CODE: INTVM-CDC. For use in Orthopedic / spinal...ZavationNDN
Z-1717-2021Class II11G DIRECT SINGLE - DELIVERY (4 FILLERS-4 SYRINGES) CODE: INTVMN-SCDK. For use in...ZavationNDN
Z-1716-2021Class II10 GAUGE DIRECT ACCESS DIAMOND TIP, CODE: INTVM-DWCd. For use in Orthopedic / spinal...ZavationNDN
Z-1715-2021Class II10G DIRECT SINGLE - ACCESS, CODE INTVM-DSBAK. For use in Orthopedic / spinal procedures.ZavationNDN
Z-1714-2021Class II10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), CODE INTVM-DSSKbd. For use in...ZavationNDN
Z-1713-2021Class IIZVplasty Direct Bipedicular Bone Access Kit with Drill, 11 Gauge, REF VCF-DDBAK-11. For...ZavationNDN
Z-1712-2021Class IIZVplasty Direct Access Diamond Tip Trocar, 11 Gauge, REF VCF-1023-11. For use in...ZavationNDN
Z-1711-2021Class IIZVplasty Direct Access Bevel Tip Trocar, 11 Gauge, REF VCF-1022-11. For use in...ZavationNDN
Z-1710-2021Class IIZVplasty Bipedicular Cement Delivery Cannula, 11 Gauge, REF VCF-DCDK-11. For use in...ZavationNDN
Z-1709-2021Class IIZVplasty Unipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCG-SCDK. For use in...ZavationNDN
Z-1708-2021Class IIZVplasty Direct Unipedicular Bone Access Kit with Drill, 10 Gauge, REF VCF-DSBAK. For...ZavationNDN
Z-1707-2021Class IIZVplasty, Direct Bipedicular, Bone Access Kit with Coxaial Cannula, REF VCF-DDSKbd. For...ZavationNDN
Z-1706-2021Class IIZVplasty Direct Bipedicular Bone Access Kit with Drill, 10 Gauge, VCF-DDBAK. For use in...ZavationNDN
Z-1705-2021Class IIZVplasty, Bipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCF-DCDK. For use in...ZavationNDN
Z-1704-2021Class IIZVplasty Direct Access Diamond Tip Trocar, 10 Gauge, REF VCF-1023. For use in Orthopedic...ZavationNDN
Z-1703-2021Class IIZVplasty Direct Access Beveled Tip Trocar, 10 Gauge, REF VCF-1022. For use in Orthopedic...ZavationNDN