Medtronic Sofamor Danek USA Inc

FDA recalling firm · 31 enforcement events · 85 product records · 2012–2025 · TN

Medtronic Sofamor Danek USA Inc has 31 FDA enforcement events on this register (85 product records) between 2012 and 2025: 31 device; the busiest year was 2023 with 6.

0% of its events are Class I; the most common class is Class II (31). 8 events are listed as ongoing; the recalling firm's address is in TN.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
16 Sep 2025	Catalyft PL & PL40 Expandable Interbody System labeled as follows with corresponding model numbers: 1. SPACER 6068073 CATALYFT PL SHORT 7MM. Model Number: 6068073. 2. SPACER 6068076 CATALYFT PL LONG 7MM, Model Number: 6068076. 3. SPACER 6068093 CATALYFT PL SHORT 9MM, Model Number: 6068093. 4. SPACER 6068096 CATALYFT…	Device	Class II	1	Ongoing
26 Sep 2023	Grafton DBM Crunch, Model Numbers: T44115, Demineralized Bone Matrix	Device	Class II	7	Ongoing
31 Jul 2023	Magnifuse Bone Graft, Large, Size: 14mm x 25mm, REF 7509014, Human Tissue, Demineralized Bone Matrix, sterile.	Device	Class II	1	Ongoing
12 Jul 2023	CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K	Device	Class II	1	Ongoing
6 Jun 2023	Medtronic Catalyft LS Expandable Interbody System, Anterier Standalone Cage, REF 981023322, spinal implant	Device	Class II	7	Ongoing
16 Feb 2023	INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 24mm, REF 3604024; for immobilization and stabilization of spinal segment as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical unction, the cervical spine (C1 to C7), and the thoracic spine…	Device	Class II	5	Ongoing
8 Feb 2023	Medtronic Grafton Putty: a) DBM S43101 GRAFTON 0.5CC PUTTY, REF S43101; b) DBM S43102 GRAFTON 1CC PUTTY, REF S43102; c) DBM S43103 GRAFTON 2.5CC PUTTY, REF S43103; d) DBM S43105 GRAFTON 5CC PUTTY, REF S43105; e) DBM S43110 GRAFTON 10CC PUTTY, REF S43110; f) DBM T43101 0.5CC GRAFTON PUTTY, REF T43101; g) DBM T43101INT…	Device	Class II	12	Ongoing
19 Nov 2021	Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set, Loaner Kit Number SPS03139; for use in spinal surgery	Device	Class II	1	Ongoing
2 Sep 2021	Endoskeleton" TAS Interbody System with Titan nanoLOCK" Surface Technology, Nanolock 12 Dg Interbody, Large, 12mm	Device	Class II	2	Terminated
27 Apr 2021	Braive Growth Modulation System Break-Off Set Screws - Product Usage: intended to limit further progression of the spinal curvature and provide correction of the thoracic curve while allowing continued skeletal growth by compression of the convex side of the scoliotic curve.	Device	Class II	1	Terminated
17 Mar 2021	Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Small, 8 mm, Product Number 5146-1208-N - Product Usage: indicated to be used with supplemental fixation cleared by the FDA for use in the cervical spine and autograft bone, allograft bone comprised of cancellous and/or…	Device	Class II	2	Terminated
8 Jun 2020	Accurian RF Ablation, Cannula pk, Accurian, 100mm, 18G, 10mm, CS Product Number: AC0005 GTIN /UPN: 20763000153551 - Product Usage: (sterile, single-use) comprises an electrically insulated shaft, an active electrode for RF energy delivery, a hub with a female slip luer fitting, and a stylet with a color-coded cap to…	Device	Class II	6	Terminated
24 Apr 2020	Extremities, Large Kit Assy, US, 15/3 - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. The single-use Medtronic Bone Void Filler Kit contains the necessary components for mixing of the bone void filler.	Device	Class II	3	Terminated
26 Mar 2020	VERTEX SELECT MULTI AXIAL SCREW. 4.0 X 38MM MULTI AXIAL SCREW. Lot H5517628	Device	Class II	1	Terminated
27 Sep 2018	INFUSE Bone Graft X SMALL KIT REF 7510100	Device	Class II	1	Terminated
9 Jul 2018	Medtronic CD HORIZON Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, or sacral spine.MULTI-AXIAL SCREW FOR 5.5/6.0MM RODS, REF 55840005045	Device	Class II	1	Terminated
23 Mar 2018	Medtronic ZEVO(TM) Anterior Cervical Plate System SLOT SCREW, REF 7710015, Size 4.5mm x 15mm Product Appliance, fixation, spinal intervertebral body	Device	Class II	1	Terminated
13 Mar 2018	Medtronic Prestige LP(TM) Cervical Disc System with Streamlined Instruments, DRILL GUIDES: a) REF 6975205, 5mm b) REF 6975206, 6mm c) REF 6975207, 7mm Product Usage: The PRESTIGE LP reusable instruments are intended for the surgical implantation of the PRESTIGE LP Cervical Disc. Medtronic reusable instruments must be…	Device	Class II	1	Terminated
22 Dec 2017	Medtronic ANGLED DRILL, REF 6630902, QTY: 1 EA Rx only	Device	Class II	1	Terminated
6 Dec 2017	Medtronic KYPHON(R) Express(TM) Directional Bone Filler Device, SIZE 2, REF FB, QTY 1 EA, Rx only STERILE R	Device	Class II	1	Terminated
17 May 2017	KYPHON(R) Directional Bone Filler Device, Size: 3, REF F04C, Rx Only, STERILE R.	Device	Class II	1	Terminated
13 Apr 2017	Medtronic PAK NEEDLE BEVELED AND TROCAR TIPS, REF 8670009, QTY 1 EA, STERILE R, Rx only	Device	Class II	1	Terminated
20 Feb 2017	Poly Component Trial, MPCS, packaged in the following sizes and configurations: a) Poly Component Trial - MPCS 3x10L, REF 90-SRK-192310 b) Poly Component Trial - MPCS 3x10R, REF 90-SRK-191310 c) Poly Component Trial - MPCS 3x12L, REF 90-SRK-192312 d) Poly Component Trial - MPCS 3x12R, REF 90-SRK-191312 e) Poly…	Device	Class II	4	Terminated
18 Jul 2016	RESPONSIVE, KNEE: FEMORAL COMPONENT CR/CS, SIZE 3R, REF 90-SRK-311300, QTY: 1, STERILE R,	Device	Class II	8	Terminated
13 Jan 2015	KYPHON EXPRESS, Osteo Introducer System, Diamond and Bevel, Size 2, REF T34A, QTY: 1EA, Rx only, STERILE R. For use with spinal fixation devices.	Device	Class II	1	Terminated
3 Dec 2014	POWEREASE Instruments Set Screw Breakoff Instrument, REF 2346010, Medtronic Sofamor Danek, USA, Inc. Spinal surgical instrumrent.	Device	Class II	1	Terminated
6 Jan 2014	Medtronic GRAFTON (R) DBM, Flex 2.5cm x 10cm, REF T42100, Rx only, STERILE A, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc., 1800 Pyramid Place, Memphis, TN 38132 Orthopaedic - filler, bone void	Device	Class II	1	Terminated
3 Jan 2014	SET SCREW RETAINING DRIVER, REF 9010000820, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc. Screwdriver - orthopedic manual surgical instrument.	Device	Class II	1	Terminated
12 Aug 2013	T8 REMOVAL HEAD, REF 8910641, QTY: 1 EA, Product Usage: The non-sterile T8 Removal Diriver is used with the Spire and Spire Z Spinal System in conjunction with the set screwdriver to remove the implant during removal surgery. The set screw driver is attached to the end of the removal head and used to disengage the…	Device	Class II	1	Terminated
28 May 2013	INFUSE(R) Bone Graft, SMALL KIT, REF 7510200, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic	Device	Class II	7	Terminated
30 Aug 2012	ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 176-503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the…	Device	Class II	3	Terminated

By type and class

Device31

Class II31

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for Medtronic Sofamor Danek USA Inc by year initiated.

Questions and answers

How many FDA recalls has Medtronic Sofamor Danek USA Inc had?

31 enforcement events (85 product records) on this register, 2012–2025: 31 device.

Are any Medtronic Sofamor Danek USA Inc recalls ongoing?

8 events are listed as ongoing in the current openFDA export.

What class are Medtronic Sofamor Danek USA Inc recalls?

31 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.