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Medtronic Sofamor Danek USA Inc

137 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Catalyft PL & PL40 Expandable Interbody System labeled as follows with corresponding model recall (Z-0580-2026)Medtronic Sofamor Danek USA Inc2025-11-21
Grafton DBM Crunch, Model Numbers: T44115, Demineralized Bone Matrix recall (Z-0161-2024)Medtronic Sofamor Danek USA Inc2023-10-25
Grafton DBM (Flex), Model Numbers: T42100, Demineralized Bone Matrix recall (Z-0162-2024)Medtronic Sofamor Danek USA Inc2023-10-25
Grafton DMB Matrix, Model Numbers: a) T42200, b) T42210; Demineralized Bone Matrix recall (Z-0163-2024)Medtronic Sofamor Danek USA Inc2023-10-25
Grafton DBM Matrix Strips, Model Numbers: a) T42275, b) T42280; Demineralized Bone Matrix recall (Z-0164-2024)Medtronic Sofamor Danek USA Inc2023-10-25
Grafton DBM Orthoblend, Model Numbers: a) T44125INT, b) T44135, c) T44145, d) T44150; Demi recall (Z-0165-2024)Medtronic Sofamor Danek USA Inc2023-10-25
Grafton Plus DBM Paste, Model Numbers: a) T45001, b) T45005, c) T45010; Demineralized Bone recall (Z-0166-2024)Medtronic Sofamor Danek USA Inc2023-10-25
Grafton DBM Putty, Model Numbers: a) T43102, b) T43102INT, c) T43103INT, d) T43105, e) T43 recall (Z-0167-2024)Medtronic Sofamor Danek USA Inc2023-10-25
Magnifuse Bone Graft, Large, Size: 14mm x 25mm, REF 7509014, Human Tissue, Demineralized B recall (Z-2524-2023)Medtronic Sofamor Danek USA Inc2023-09-08
CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K recall (Z-2363-2023)Medtronic Sofamor Danek USA, Inc2023-08-09
Medtronic Catalyft LS Expandable Interbody System, Anterier Standalone Cage, REF 981023322 recall (Z-2117-2023)Medtronic Sofamor Danek USA Inc2023-07-10
Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981023325 recall (Z-2118-2023)Medtronic Sofamor Danek USA Inc2023-07-10
Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981025522 recall (Z-2119-2023)Medtronic Sofamor Danek USA Inc2023-07-10
Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981025525 recall (Z-2120-2023)Medtronic Sofamor Danek USA Inc2023-07-10
Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027722 recall (Z-2121-2023)Medtronic Sofamor Danek USA Inc2023-07-10
Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027725 recall (Z-2122-2023)Medtronic Sofamor Danek USA Inc2023-07-10
Medtronic Catalyft LS Expandable Interbody System Implant Kit, Anterior Standalone Cage, R recall (Z-2123-2023)Medtronic Sofamor Danek USA Inc2023-07-10
Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set, Loaner Kit recall (Z-1574-2023)Medtronic Sofamor Danek USA Inc2023-05-10
INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 24mm, RE recall (Z-1409-2023)Medtronic Sofamor Danek USA Inc2023-04-19
INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 32mm, RE recall (Z-1410-2023)Medtronic Sofamor Danek USA Inc2023-04-19
INFINITY Occipitocervical Upper Thoracic System, PARTIALLY THREADED MULTI AXIAL SCREW, Siz recall (Z-1411-2023)Medtronic Sofamor Danek USA Inc2023-04-19
INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 26mm, RE recall (Z-1412-2023)Medtronic Sofamor Danek USA Inc2023-04-19
INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 34mm, RE recall (Z-1413-2023)Medtronic Sofamor Danek USA Inc2023-04-19
Medtronic Grafton Putty: a) DBM S43101 GRAFTON 0.5CC PUTTY, REF S43101; b) DBM S43102 GRAF recall (Z-1323-2023)Medtronic Sofamor Danek USA Inc2023-04-04
Medtronic Grafton Crunch a) DBM S44105 GRAFTON 5CC CRUNCH, REF S44105; b) DBM S44115 GRAFT recall (Z-1324-2023)Medtronic Sofamor Danek USA Inc2023-04-04
Medtronic Grafton Flex: a) DBM S42090 GRAFTON 1.5CM X 1.5CM FLEX, REF S42090; b) DBM T4209 recall (Z-1325-2023)Medtronic Sofamor Danek USA Inc2023-04-04
Medtronic Grafton Orthoblend: a) DBM S44125 5CC ORTHOBLEND LARGE DEFECT, REF S44125; b) DB recall (Z-1326-2023)Medtronic Sofamor Danek USA Inc2023-04-04
Medtronic Grafton Matrix: a) DBM S42200 GRAFTON 2.5CMX10CM 2EA MATRIX, REF S42200; b) DBM recall (Z-1327-2023)Medtronic Sofamor Danek USA Inc2023-04-04
Medtronic Grafton Matrix Strips: a) DBM S42275 8MMX1CMX10CM 2EA MATRIX STRPS, REF S42275; recall (Z-1328-2023)Medtronic Sofamor Danek USA Inc2023-04-04
Medtronic Grafton Plus Paste a) DBM S45001 GRAFTON 1CC PASTE, REF S45001; b) DBM S45005 GR recall (Z-1329-2023)Medtronic Sofamor Danek USA Inc2023-04-04
Medtronic Grafton DBF: a) PUTTY T50101 GRAFTON DBF 1CC, REF T50101; b) PUTTY T50101INT GRA recall (Z-1330-2023)Medtronic Sofamor Danek USA Inc2023-04-04
Medtronic Grafton DBF Inject: a) GRAFTON T50303 DBF INJECT 3CC, REF T50303; b) GRAFTON T50 recall (Z-1331-2023)Medtronic Sofamor Danek USA Inc2023-04-04
Medtronic Accelerate Grafton DBF a) ACCELERATE BG SET T50203 GRAFTON DBF 3CC, REF T50203; recall (Z-1332-2023)Medtronic Sofamor Danek USA Inc2023-04-04
Medtronic Grafton Gel: a) DBM S41120 GRAFTON GEL 1CC, REF S41120; b) DBM S41150 GRAFTON GE recall (Z-1333-2023)Medtronic Sofamor Danek USA Inc2023-04-04
Medtronic XPANSE Bone Insert: a) DBM T600106 XPANSE SMALL-C 6, REF T600106; b) DBM T600206 recall (Z-1334-2023)Medtronic Sofamor Danek USA Inc2023-04-04
KYPHON EXPRESS, Osteo Introducer System, Diamond and Bevel, Size 2, REF T34A, QTY: 1EA, Rx recall (Z-1057-2015)Medtronic Sofamor Danek USA Inc2015-02-05
POWEREASE Instruments Set Screw Breakoff Instrument, REF 2346010, Medtronic Sofamor Danek, recall (Z-0952-2015)Medtronic Sofamor Danek USA Inc2015-01-12
Medtronic GRAFTON (R) DBM, Flex 2.5cm x 10cm, REF T42100, Rx only, STERILE A, QTY: 1 EA, M recall (Z-0977-2014)Medtronic Sofamor Danek USA Inc2014-02-12
SET SCREW RETAINING DRIVER, REF 9010000820, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc. recall (Z-0866-2014)Medtronic Sofamor Danek USA Inc2014-01-30
T8 REMOVAL HEAD, REF 8910641, QTY: 1 EA, Product Usage: The non-sterile T8 Removal Diriver recall (Z-2200-2013)Medtronic Sofamor Danek USA Inc2013-09-14
INFUSE(R) Bone Graft, SMALL KIT, REF 7510200, Medtronic Sofamore Danek USA, Inc., 1800 Pyr recall (Z-1589-2013)Medtronic Sofamor Danek USA Inc2013-06-25
INFUSE(R) Bone Graft, MEDIUM KIT, REF 7510400, Medtronic Sofamore Danek USA, Inc., 1800 Py recall (Z-1590-2013)Medtronic Sofamor Danek USA Inc2013-06-25
INFUSE(R) Bone Graft, LARGE KIT, REF 7510600, Medtronic Sofamore Danek USA, Inc., 1800 Pyr recall (Z-1591-2013)Medtronic Sofamor Danek USA Inc2013-06-25
INFUSE(R) Bone Graft,LARGE II KIT, REF 7510800, Medtronic Sofamore Danek USA, Inc., 1800 P recall (Z-1592-2013)Medtronic Sofamor Danek USA Inc2013-06-25
INFUSE(R) Bone Graft, SMALL KIT, REF 7510200AUS, Medtronic Sofamore Danek USA, Inc., 1800 recall (Z-1593-2013)Medtronic Sofamor Danek USA Inc2013-06-25
INFUSE(R) Bone Graft, MEDIUM KIT, REF 7510400AUS, Medtronic Sofamore Danek USA, Inc., 1800 recall (Z-1594-2013)Medtronic Sofamor Danek USA Inc2013-06-25
INFUSE(R) Bone Graft, LARGE II KIT, REF 7510800AUS, Medtronic Sofamore Danek USA, Inc., 18 recall (Z-1595-2013)Medtronic Sofamor Danek USA Inc2013-06-25
ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 176-503, QTY: recall (Z-0036-2013)Medtronic Sofamor Danek USA Inc2012-10-10
ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-504, QTY: 1 E recall (Z-0037-2013)Medtronic Sofamor Danek USA Inc2012-10-10
PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 EA, Rx only, Me recall (Z-0038-2013)Medtronic Sofamor Danek USA Inc2012-10-10
ATLANTIS(TM) Anterior Cervical Plate System Adjustable Drill Stop, REF 876-460, QTY: 1 EA, recall (Z-1442-2012)Medtronic Sofamor Danek USA Inc2012-04-19
PREMIER(R) Anterior Cervical Plate System Adjustable Drill Stop, REF 6905712, QTY: 1 EA, R recall (Z-1443-2012)Medtronic Sofamor Danek USA Inc2012-04-19
VERTEX MAX (R) Cannulated, VERTEX MAX (R), and VERTEX (R) Reconstruction System Adjustable recall (Z-1444-2012)Medtronic Sofamor Danek USA Inc2012-04-19
CD HORIZON (R) Spinal System, MULTI-AXIAL SCREW FOR 5.5mm ROD W/DUAL LEAD THREAD, Size 6.5 recall (Z-0464-2012)Medtronic Sofamor Danek USA Inc2012-01-11
CD HORIZON (R) Spinal System, MULTI-AXIAL SCREW FOR 5.5mm ROD W/REDUCTION HEAD, Size 6.5mm recall (Z-0465-2012)Medtronic Sofamor Danek USA Inc2012-01-11
TSRH(R) Spinal System SCREW, REF 837-645, Size: 6.5mm x 45mm, Mat'l: TITANIUM ALLOY, Rx on recall (Z-3044-2011)Medtronic Sofamor Danek USA Inc2011-08-19
ATLANTIS(R) Anterior Cervical Plate System Screw Caddy; Self Tapping Variable Screw Caddy recall (Z-2984-2011)Medtronic Sofamor Danek USA Inc2011-08-10
ATLANTIS(R) Anterior Cervical Plate System Screw Caddy; Self Drilling Fixed Screw Caddy (9 recall (Z-2985-2011)Medtronic Sofamor Danek USA Inc2011-08-10
CD HORIZON (R) LEGACY (TM) FAS, REF 7542535, pedicle screw, Rx only, Medtronic Sofamor Dan recall (Z-2874-2011)Medtronic Sofamor Danek USA Inc2011-07-25
CD HORIZON (R) LEGACY (TM) MAS, REF 75445540, pedicle screw, Rx only, Medtronic Sofamor Da recall (Z-2875-2011)Medtronic Sofamor Danek USA Inc2011-07-25
CD HORIZON (R) SOLERA (TM) FAS, REF 54410006035, pedicle screw, Rx only, Medtronic Sofamor recall (Z-2876-2011)Medtronic Sofamor Danek USA Inc2011-07-25
VERTEX (R), REF 69004440, cortical screw, Rx only, Medtronic Sofamor Danek USA, 1800 Pyram recall (Z-2877-2011)Medtronic Sofamor Danek USA Inc2011-07-25
ATLANTIS (R) Self-Tapping Variable Angle Screw, Rx only, Medtronic Sofamor Danek USA, 1800 recall (Z-2878-2011)Medtronic Sofamor Danek USA Inc2011-07-25
Medtronic Sofamor Danek Extended Length Trocar, Item No.: 7578013, Mat'l: Stainless Steel, recall (Z-0606-2010)Medtronic Sofamor Danek USA Inc2010-01-12
Medtronic Sofamor Danek Extended Length Trocar, Size : L=50MM, Item No.: 7578014, Mat'l: S recall (Z-0607-2010)Medtronic Sofamor Danek USA Inc2010-01-12
Medtronic INTREPID Spinal System SPACER, 32X23, 8 DEG, Size: 10MM, Part Number: REF 796181 recall (Z-1796-2009)Medtronic Sofamor Danek USA Inc2009-07-24
Medtronic INTREPID Spinal System SPACER, 32X23, 12 DEG, Size: 10MM, Part Number: REF 79612 recall (Z-1797-2009)Medtronic Sofamor Danek USA Inc2009-07-24
Medtronic INTREPID Spinal System SPACER M 37X27, 8 DEG, Size 10MM, Part Number: REF 796281 recall (Z-1798-2009)Medtronic Sofamor Danek USA Inc2009-07-24
Medtronic INTREPID Spinal System SPACER M 37X27, 12 DEG, Size: 10MM, Part Number: REF 7962 recall (Z-1799-2009)Medtronic Sofamor Danek USA Inc2009-07-24
Medtronic INTREPID Spinal System SPACER L 42X30, 8 DEG, Size: 10MM: Part Number: REF 79638 recall (Z-1800-2009)Medtronic Sofamor Danek USA Inc2009-07-24
Medtronic INTREPID Spinal System SPACER L 42X30, 12 DEG, Size: 10MM, Part Number: REF 7963 recall (Z-1801-2009)Medtronic Sofamor Danek USA Inc2009-07-24
Medtronic INTREPID Spinal System Coverplate, size: Small, Part Number: REF 7961330; medium recall (Z-1802-2009)Medtronic Sofamor Danek USA Inc2009-07-24
Medtronic SOFAMOR DANEK INTREPID SPINAL SYSTEM, 5.5MM TAPERED SCREW, Length: 20MM, , Part recall (Z-1803-2009)Medtronic Sofamor Danek USA Inc2009-07-24
Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, recall (Z-1408-2008)Medtronic Sofamor Danek USA Inc2008-09-11
Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, recall (Z-1409-2008)Medtronic Sofamor Danek USA Inc2008-09-11
Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, recall (Z-1410-2008)Medtronic Sofamor Danek USA Inc2008-09-11
Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, recall (Z-1411-2008)Medtronic Sofamor Danek USA Inc2008-09-11
Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, recall (Z-1412-2008)Medtronic Sofamor Danek USA Inc2008-09-11
Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, recall (Z-1413-2008)Medtronic Sofamor Danek USA Inc2008-09-11
Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, recall (Z-1414-2008)Medtronic Sofamor Danek USA Inc2008-09-11
Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, recall (Z-1415-2008)Medtronic Sofamor Danek USA Inc2008-09-11
Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, recall (Z-1416-2008)Medtronic Sofamor Danek USA Inc2008-09-11
Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, recall (Z-1417-2008)Medtronic Sofamor Danek USA Inc2008-09-11
Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, recall (Z-1418-2008)Medtronic Sofamor Danek USA Inc2008-09-11
Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, recall (Z-1419-2008)Medtronic Sofamor Danek USA Inc2008-09-11
Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, recall (Z-1420-2008)Medtronic Sofamor Danek USA Inc2008-09-11
Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, recall (Z-1421-2008)Medtronic Sofamor Danek USA Inc2008-09-11
Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, recall (Z-1422-2008)Medtronic Sofamor Danek USA Inc2008-09-11
Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, recall (Z-1423-2008)Medtronic Sofamor Danek USA Inc2008-09-11
Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, recall (Z-1424-2008)Medtronic Sofamor Danek USA Inc2008-09-11
Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, recall (Z-1425-2008)Medtronic Sofamor Danek USA Inc2008-09-11
Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, recall (Z-1426-2008)Medtronic Sofamor Danek USA Inc2008-09-11
Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, recall (Z-1427-2008)Medtronic Sofamor Danek USA Inc2008-09-11
Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, recall (Z-1428-2008)Medtronic Sofamor Danek USA Inc2008-09-11
Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, recall (Z-1429-2008)Medtronic Sofamor Danek USA Inc2008-09-11
Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, recall (Z-1430-2008)Medtronic Sofamor Danek USA Inc2008-09-11
Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, recall (Z-1431-2008)Medtronic Sofamor Danek USA Inc2008-09-11
Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, recall (Z-1432-2008)Medtronic Sofamor Danek USA Inc2008-09-11
Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, recall (Z-1433-2008)Medtronic Sofamor Danek USA Inc2008-09-11
Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, recall (Z-1434-2008)Medtronic Sofamor Danek USA Inc2008-09-11
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Every clearance here is in the API, with alerts when new ones post.