Medtronic Sofamor Danek USA Inc: 26 recalls on record

Recalls filed with 1 agency: FDA (26).

First recall on record: October 17, 2012. Most recent: November 1, 2023.

Risk classification: Class II: 26

Most recent recalls

DateAgencyProduct
November 1, 2023FDAGrafton DMB Matrix, Model Numbers: a) T42200, b) T42210; Demineralized Bone MatrixZ-0163-2024
October 20, 2021FDAEndoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 D…Z-0086-2022
July 29, 2020FDAAccurian RF Ablation, Cannula pk, Accurian, 150mm, 20G, 10mm, CS Product Number: AC0012 G…Z-2693-2020
May 20, 2020FDAVERTEX SELECT MULTI AXIAL SCREW. 4.0 X 38MM MULTI AXIAL SCREW. Lot H5517628Z-1941-2020
June 14, 2017FDAKYPHON(R) Directional Bone Filler Device, Size: 3, REF F04C, Rx Only, STERILE R.Z-2247-2017
May 17, 2017FDAMedtronic PAK NEEDLE BEVELED AND TROCAR TIPS, REF 8670009, QTY 1 EA, STERILE R, Rx onlyZ-2047-2017
March 29, 2017FDAPoly Component Trial, UCCS, packaged in the following sizes and configurations: a) Pol…Z-1514-2017
August 31, 2016FDATIBIAL TRAY , SIZE 5, REF 90-SRK-200500, QTY: 1, STERILE R, Responsive Orthopedics, tot…Z-2638-2016
August 31, 2016FDARESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 5R, REF 90-SRK…Z-2633-2016
August 31, 2016FDATIBIAL TRAY , SIZE 2, REF 90-SRK-200200, QTY: 1, STERILE R, total knee replacement .Z-2635-2016
July 6, 2016FDASaw Sagittal Catalog Number: ES 300; Saw Sagittal Refurbished Catalog Number: ES300-R; Sa…Z-2085-2016
May 11, 2016FDAMedtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM. Intended for use in neuros…Z-1602-2016
February 11, 2015FDAKYPHON EXPRESS, Osteo Introducer System, Diamond and Bevel, Size 2, REF T34A, QTY: 1EA, R…Z-1057-2015
February 19, 2014FDAMedtronic GRAFTON (R) DBM, Flex 2.5cm x 10cm, REF T42100, Rx only, STERILE A, QTY: 1 EA, …Z-0977-2014
February 5, 2014FDASET SCREW RETAINING DRIVER, REF 9010000820, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc.…Z-0866-2014
September 25, 2013FDAT8 REMOVAL HEAD, REF 8910641, QTY: 1 EA, Product Usage: The non-sterile T8 Removal D…Z-2200-2013
July 3, 2013FDAINFUSE(R) Bone Graft, LARGE II KIT, REF 7510800AUS, Medtronic Sofamore Danek USA, Inc., 1…Z-1595-2013
July 3, 2013FDAINFUSE(R) Bone Graft, SMALL KIT, REF 7510200, Medtronic Sofamore Danek USA, Inc., 1800 Py…Z-1589-2013
July 3, 2013FDAINFUSE(R) Bone Graft, MEDIUM KIT, REF 7510400, Medtronic Sofamore Danek USA, Inc., 1800 P…Z-1590-2013
July 3, 2013FDAINFUSE(R) Bone Graft,LARGE II KIT, REF 7510800, Medtronic Sofamore Danek USA, Inc., 1800 …Z-1592-2013
July 3, 2013FDAINFUSE(R) Bone Graft, LARGE KIT, REF 7510600, Medtronic Sofamore Danek USA, Inc., 1800 Py…Z-1591-2013
July 3, 2013FDAINFUSE(R) Bone Graft, MEDIUM KIT, REF 7510400AUS, Medtronic Sofamore Danek USA, Inc., 180…Z-1594-2013
July 3, 2013FDAINFUSE(R) Bone Graft, SMALL KIT, REF 7510200AUS, Medtronic Sofamore Danek USA, Inc., 1800…Z-1593-2013
October 17, 2012FDAATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-504, QTY: 1…Z-0037-2013
October 17, 2012FDAPREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 EA, Rx only, …Z-0038-2013

Questions about this company

How many recalls does Medtronic Sofamor Danek USA Inc have?
Recalert has 26 U.S. recalls on record for Medtronic Sofamor Danek USA Inc, published between October 17, 2012 and November 1, 2023.
What was the most recent Medtronic Sofamor Danek USA Inc recall?
FDA recall Z-0163-2024, published November 1, 2023: Grafton DMB Matrix, Model Numbers: a) T42200, b) T42210; Demineralized Bone Matrix
Which agencies have handled Medtronic Sofamor Danek USA Inc recalls?
Medtronic Sofamor Danek USA Inc appears as the recalling firm in recalls from: FDA (26).

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