PlainRecalls

Medtronic Sofamor Danek USA Inc

Compiled from official public sources by the publisher.

85 recalls on record · Latest: Dec 3, 2025

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Agency notice ledger

Federal filing book Medtronic Sofamor Danek USA… MID-BOOK · SINGLE-AGENCY

#210 of 14,151 · 85 notices · 0.081% archive

  • BOOK 85 notices
  • RANK #210 of 14,151
  • SHARE 0.081% archive
  • AGENCY FDA Devices (85)
  • CAT medical devices
  • CATS 1 category
  • LATEST Dec 3, 2025
  • PHOTO Cook Incorporated

Nearest notice-volume peer: Cook Incorporated (0 notice gap)

Medtronic Sofamor Danek USA Inc accounts for about 0.081% of the 104,423-notice archive on 85 distinct filings — a heavy share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

Where Medtronic Sofamor Danek USA… sits among 14,151 recalling firms

Medtronic Sofamor Danek USA Inc ranks 210th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Medtronic Sofamor Danek USA… vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

85 210th of 14151 higher than 13,941 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13

Medtronic Sofamor Danek USA… in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Medtronic Sofamor Danek USA Inc holds about 0.081% of archive notices alongside 85 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Moderate Nov 21, 2018

INFUSE Bone Graft X SMALL KIT REF 7510100
FDA Devices Moderate Aug 15, 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
FDA Devices Moderate May 16, 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 sterilized prior to initial use and must be cleaned and sterilized prior to each re-use.
FDA Devices Moderate May 16, 2018

Medtronic ZEVO(TM) Anterior Cervical Plate System SLOT SCREW, REF 7710015, Size 4.5mm x 15mm Product Appliance, fixation, spinal intervertebral body
FDA Devices Moderate Feb 21, 2018

Medtronic ANGLED DRILL, REF 6630902, QTY: 1 EA Rx only
FDA Devices Moderate Jan 24, 2018

Medtronic KYPHON(R) Express(TM) Directional Bone Filler Device, SIZE 2, REF FB, QTY 1 EA, Rx only STERILE R
FDA Devices Moderate Jun 14, 2017

KYPHON(R) Directional Bone Filler Device, Size: 3, REF F04C, Rx Only, STERILE R.
FDA Devices Moderate May 17, 2017

Medtronic PAK NEEDLE BEVELED AND TROCAR TIPS, REF 8670009, QTY 1 EA, STERILE R, Rx only
FDA Devices Moderate Mar 29, 2017

Poly Component Trial, UCCS, packaged in the following sizes and configurations: a) Poly Comp Trial - UCCS 3x10, REF 90-SRK-170310 b) Poly Comp Trial - UCCS 3x12, REF 90-SRK-170312 c) Poly Comp Trial - UCCS 3x14, REF 90-SRK-170314 d) Poly Comp Trial - UCCS 4x10, REF 90-SRK-170410 e) Poly Comp Trial - UCCS 4x12, REF 90-SRK-170412 f) Poly Comp Trial - UCCS 4x14, REF 90-SRK-170414 g) Poly Comp Trial - UCCS 5x10, REF 90-SRK-170510 h) Poly Comp Trial - UCCS 5x12, REF 90-SRK-170512 i) Poly C
FDA Devices Moderate Mar 29, 2017

Poly Component Trial, CR, packaged in the following sizes and configurations: a) Poly Component Trial - CR 3x10, REF 90-SRK-160310 b) Poly Component Trial - CR 3x12, REF 90-SRK-160312 c) Poly Component Trial - CR 3x14, REF 90-SRK-160314 d) Poly Component Trial - CR 4x10, REF 90-SRK-160410 e) Poly Component Trial - CR 4x12, REF 90-SRK-160412 f) Poly Component Trial - CR 4x14, REF 90-SRK-160414 g) Poly Component Trial - CR 5x10,REF 90-SRK-160510 h) Poly Component Trial - CR 5x12, REF 90-
FDA Devices Moderate Mar 29, 2017

Poly Component Trial, PS, packaged in the following sizes and configurations: a) Poly Component Trial - PS 3x10, REF 90-SRK-180310 b) Poly Component Trial - PS 3x12, REF 90-SRK-180312 c) Poly Component Trial - PS 3x14, REF 90-SRK-180314 d) Poly Component Trial - PS 4x10, REF 90-SRK-180410 e) Poly Component Trial - PS 4x12, REF 90-SRK-180412 f) Poly Component Trial - PS 4x14, REF 90-SRK-180414 g) Poly Component Trial - PS 5x10, REF 90-SRK-180510 h) Poly Component Trial - PS 5x12, REF 90
FDA Devices Moderate Mar 29, 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 Component Trial - MPCS 3x14L, REF 90-SRK-192314 f) Poly Component Trial - MPCS 3x14R, REF 90-SRK-191314 g) Poly Component Trial - MPCS 4x10L, REF 90-SRK-192410 h) Poly Component

FDA Devices Moderate Aug 31, 2016

TIBIAL TRAY , SIZE 5, REF 90-SRK-200500, QTY: 1, STERILE R, Responsive Orthopedics, total knee replacement
FDA Devices Moderate Aug 31, 2016

TIBIAL TRAY , SIZE 2, REF 90-SRK-200200, QTY: 1, STERILE R, total knee replacement .
FDA Devices Moderate Aug 31, 2016

RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 5R, REF 90-SRK-311500, QTY: 1, STERILE R,
FDA Devices Moderate Aug 31, 2016

RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 4R, REF 90-SRK-311400, QTY: 1, STERILE R,
FDA Devices Moderate Aug 31, 2016

TIBIAL TRAY , SIZE 4, REF 90-SRK-200400, QTY: 1, STERILE R, Responsive Orthopedics, total knee replacement
FDA Devices Moderate Aug 31, 2016

RESPONSIVE, KNEE: FEMORAL COMPONENT CR/CS, SIZE 3R, REF 90-SRK-311300, QTY: 1, STERILE R,
FDA Devices Moderate Aug 31, 2016

TIBIAL TRAY , SIZE 3, REF 90-SRK-200300, QTY: 1, STERILE R, total knee replacement
FDA Devices Moderate Aug 31, 2016

RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 3L, REF 90-SRK-312300, QTY: 1, STERILE R,
FDA Devices Moderate Feb 11, 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.
FDA Devices Moderate Jan 21, 2015

POWEREASE Instruments Set Screw Breakoff Instrument, REF 2346010, Medtronic Sofamor Danek, USA, Inc. Spinal surgical instrumrent.
FDA Devices Moderate Feb 19, 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
FDA Devices Moderate Feb 5, 2014

SET SCREW RETAINING DRIVER, REF 9010000820, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc. Screwdriver - orthopedic manual surgical instrument.
FDA Devices Moderate Sep 25, 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 remaining portion of the set screw within the device.
FDA Devices Moderate Jul 3, 2013

INFUSE(R) Bone Graft, SMALL KIT, REF 7510200, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
FDA Devices Moderate Jul 3, 2013

INFUSE(R) Bone Graft, LARGE II KIT, REF 7510800AUS, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
FDA Devices Moderate Jul 3, 2013

INFUSE(R) Bone Graft, SMALL KIT, REF 7510200AUS, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
FDA Devices Moderate Jul 3, 2013

INFUSE(R) Bone Graft, LARGE KIT, REF 7510600, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
FDA Devices Moderate Jul 3, 2013

INFUSE(R) Bone Graft, MEDIUM KIT, REF 7510400AUS, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
FDA Devices Moderate Jul 3, 2013

INFUSE(R) Bone Graft, MEDIUM KIT, REF 7510400, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
FDA Devices Moderate Jul 3, 2013

INFUSE(R) Bone Graft,LARGE II KIT, REF 7510800, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
FDA Devices Moderate Oct 17, 2012

ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-504, 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 label. Unless labeled for single use, this instrument may be re-used.
FDA Devices Moderate Oct 17, 2012

PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, 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 label. Unless labeled for single use, this instrument may be re-used.
FDA Devices Moderate Oct 17, 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 label. Unless labeled for single use, this instrument may be re-used.

Medtronic Sofamor Danek USA… carries an outsized archive share

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Similar recall count

Nearest multi-notice firms by distinct-event totals (85 here — heavy-book).

Cook Incorporated 85 Beacon Hill Medical Pharmacy, P.C. 86 Carestream Health, Inc. 86 Remel, Inc 86 ROi Cps LLC 86

Similar medical devices volume

Nearest multi-notice firms in the same narrow category lane.

Cook Incorporated 85 Carestream Health, Inc. 86 Remel, Inc 86 ROi Cps LLC 86

Frequently Asked Questions

How many federal recall notices name Medtronic Sofamor Danek USA…? ▼
PlainRecalls indexes 85 distinct federal recall events naming Medtronic Sofamor Danek USA Inc, aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Medtronic Sofamor Danek USA… sit among other recalling firms? ▼
Medtronic Sofamor Danek USA Inc ranks #210 of 14,151 by distinct recall-event count among 14,151 firms in this archive (99th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Medtronic Sofamor Danek USA…'s notices? ▼
FDA Devices accounts for 85 of this firm's 85 indexed notices.
What product category dominates Medtronic Sofamor Danek USA…'s filing book? ▼
Filings for Medtronic Sofamor Danek USA Inc span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Medtronic Sofamor Danek USA Inc: 85 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Medtronic Sofamor Danek USA Inc; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026