Medtronic Sofamor Danek USA Inc

FDA Regulatory Profile

Summary

Total Recalls
85
510(k) Clearances
178
Inspections
16
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0580-2026Class IICatalyft PL & PL40 Expandable Interbody System labeled as follows with corresponding model numbers: September 16, 2025
Z-0161-2024Class IIGrafton DBM Crunch, Model Numbers: T44115, Demineralized Bone MatrixSeptember 26, 2023
Z-0163-2024Class IIGrafton DMB Matrix, Model Numbers: a) T42200, b) T42210; Demineralized Bone MatrixSeptember 26, 2023
Z-0165-2024Class IIGrafton DBM Orthoblend, Model Numbers: a) T44125INT, b) T44135, c) T44145, d) T44150; Demineralized September 26, 2023
Z-0166-2024Class IIGrafton Plus DBM Paste, Model Numbers: a) T45001, b) T45005, c) T45010; Demineralized Bone MatrixSeptember 26, 2023
Z-0162-2024Class IIGrafton DBM (Flex), Model Numbers: T42100, Demineralized Bone MatrixSeptember 26, 2023
Z-0167-2024Class IIGrafton DBM Putty, Model Numbers: a) T43102, b) T43102INT, c) T43103INT, d) T43105, e) T43105INT, f)September 26, 2023
Z-0164-2024Class IIGrafton DBM Matrix Strips, Model Numbers: a) T42275, b) T42280; Demineralized Bone MatrixSeptember 26, 2023
Z-2524-2023Class IIMagnifuse Bone Graft, Large, Size: 14mm x 25mm, REF 7509014, Human Tissue, Demineralized Bone MatrixJuly 31, 2023
Z-2363-2023Class IICD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006KJuly 12, 2023
Z-2117-2023Class IIMedtronic Catalyft LS Expandable Interbody System, Anterier Standalone Cage, REF 981023322, spinal iJune 6, 2023
Z-2123-2023Class IIMedtronic Catalyft LS Expandable Interbody System Implant Kit, Anterior Standalone Cage, REF SPS0318June 6, 2023
Z-2119-2023Class IIMedtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981025522, spinal iJune 6, 2023
Z-2120-2023Class IIMedtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981025525, spinal iJune 6, 2023
Z-2122-2023Class IIMedtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027725, spinal iJune 6, 2023
Z-2118-2023Class IIMedtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981023325, spinal iJune 6, 2023
Z-2121-2023Class IIMedtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027722, spinal iJune 6, 2023
Z-1410-2023Class IIINFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 32mm, REF 3604532February 16, 2023
Z-1413-2023Class IIINFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 34mm, REF 3604034February 16, 2023
Z-1409-2023Class IIINFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 24mm, REF 3604024February 16, 2023

Recent 510(k) Clearances

K-NumberDeviceDate
K254165Infinity™ OCT SystemJanuary 21, 2026
K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)January 7, 2026
K253129Infinity™ OCT SystemOctober 24, 2025
K253335CD Horizon™ Spinal SystemOctober 24, 2025
K251444Endoskeleton™ Interbody SystemsSeptember 4, 2025
K251395The Rialto™ SI Fusion SystemJune 26, 2025
K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyApril 22, 2025
K241992Catalyft™ LS Expandable Interbody SystemOctober 28, 2024
K243007CD Horizon™ Spinal SystemOctober 23, 2024
K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)March 27, 2024
K233830OsteoCool™ 2.0 RF Ablation SystemFebruary 28, 2024
K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System (Modular ExteAugust 16, 2023
K231090Zevo Anterior Cervical Plate SystemJune 15, 2023
K231184CD Horizon™ Spinal SystemMay 26, 2023
K223764INFINITY OCT SystemJanuary 11, 2023
K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyDecember 16, 2022
K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™ SPINAL SYSTEM;October 4, 2022
K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth(TM) EditionSeptember 29, 2022
K221180Anteralign(TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMay 25, 2022
K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyApril 12, 2022