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Medtronic Sofamor Danek USA Recalls
85 recalls on record · October 17, 2012 to December 3, 2025 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
March 29, 2017Medical DevicesFDA
Medtronic Sofamor Danek USA Inc recalls Poly Component Trial, UCCS, packaged in the following sizes and configurations: a) Poly Comp Trial - UCCS 3x10, REF 9
Hazard: The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken.
March 29, 2017Medical DevicesFDA
Medtronic Sofamor Danek USA Inc recalls Poly Component Trial, MPCS, packaged in the following sizes and configurations: a) Poly Component Trial - MPCS 3x10L,
Hazard: The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken.
August 31, 2016Medical DevicesFDA
Medtronic Sofamor Danek USA Inc recalls TIBIAL TRAY , SIZE 5, REF 90-SRK-200500, QTY: 1, STERILE R, Responsive Orthopedics, total knee replacement
Hazard: The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.
August 31, 2016Medical DevicesFDA
Medtronic Sofamor Danek USA Inc recalls TIBIAL TRAY , SIZE 4, REF 90-SRK-200400, QTY: 1, STERILE R, Responsive Orthopedics, total knee replacement
Hazard: The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.
August 31, 2016Medical DevicesFDA
Medtronic Sofamor Danek USA Inc recalls TIBIAL TRAY , SIZE 3, REF 90-SRK-200300, QTY: 1, STERILE R, total knee replacement
Hazard: The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.
August 31, 2016Medical DevicesFDA
Medtronic Sofamor Danek USA Inc recalls TIBIAL TRAY , SIZE 2, REF 90-SRK-200200, QTY: 1, STERILE R, total knee replacement .
Hazard: The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.
August 31, 2016Medical DevicesFDA
Medtronic Sofamor Danek USA Inc recalls RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 3L, REF 90-SRK-312300, QTY: 1, STERILE R,
Hazard: The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.
August 31, 2016Medical DevicesFDA
Medtronic Sofamor Danek USA Inc recalls RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 5R, REF 90-SRK-311500, QTY: 1, STERILE R,
Hazard: The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.
August 31, 2016Medical DevicesFDA
Medtronic Sofamor Danek USA Inc recalls RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 4R, REF 90-SRK-311400, QTY: 1, STERILE R,
Hazard: The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.
August 31, 2016Medical DevicesFDA
Medtronic Sofamor Danek USA Inc recalls RESPONSIVE, KNEE: FEMORAL COMPONENT CR/CS, SIZE 3R, REF 90-SRK-311300, QTY: 1, STERILE R,
Hazard: The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.
February 11, 2015Medical DevicesFDA
Medtronic Sofamor Danek USA Inc recalls KYPHON EXPRESS, Osteo Introducer System, Diamond and Bevel, Size 2, REF T34A, QTY: 1EA, Rx only, STERILE R. For use wit
Hazard: The product, labeled as containing, one bevel-tipped instrument and one diamond-tipped instrument, may contain either two bevel-tipped instruments or two diamond-tipped instruments.
January 21, 2015Medical DevicesFDA
Medtronic Sofamor Danek USA Inc recalls POWEREASE Instruments Set Screw Breakoff Instrument, REF 2346010, Medtronic Sofamor Danek, USA, Inc. Spinal surgical in
Hazard: The retaining tabs component of the Set Screw Retaining Drive may be oversized, which will not allow proper mating between the Set Screw Retaining Drive and the set screw.
February 19, 2014Medical DevicesFDA
Medtronic Sofamor Danek USA Inc recalls Medtronic GRAFTON (R) DBM, Flex 2.5cm x 10cm, REF T42100, Rx only, STERILE A, QTY: 1 EA, Medtronic Sofamor Danek, USA, I
Hazard: Product was labeled as being measured as 2.5 cm x 10 cm, but contained product that measured as 2.5 cm x 5 cm.
February 5, 2014Medical DevicesFDA
Medtronic Sofamor Danek USA Inc recalls SET SCREW RETAINING DRIVER, REF 9010000820, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc. Screwdriver - orthopedic man
Hazard: The retaining tabs component of the Set Screw Retaining Drive may be oversized, which will not allow proper mating between the Set Screw Retaining Drive and the set screw.
September 25, 2013Medical DevicesFDA
Medtronic Sofamor Danek USA Inc recalls T8 REMOVAL HEAD, REF 8910641, QTY: 1 EA, Product Usage: The non-sterile T8 Removal Diriver is used with the Spire a
Hazard: One lot of the T8 Removal Head had incorrect hardness specification, which could result in the T8 Removal head failing during removal of the CD Horizon Spire and Spire Z Spinal System implant. There is a potential for tissue damage to occur and/or minor surgical delay to remove the remaining fragments of the tip.
July 3, 2013Medical DevicesFDA
Medtronic Sofamor Danek USA Inc recalls INFUSE(R) Bone Graft, LARGE II KIT, REF 7510800AUS, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Ten
Hazard: Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.
July 3, 2013Medical DevicesFDA
Medtronic Sofamor Danek USA Inc recalls INFUSE(R) Bone Graft, MEDIUM KIT, REF 7510400AUS, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tenne
Hazard: Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.
July 3, 2013Medical DevicesFDA
Medtronic Sofamor Danek USA Inc recalls INFUSE(R) Bone Graft, SMALL KIT, REF 7510200AUS, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennes
Hazard: Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.
July 3, 2013Medical DevicesFDA
Medtronic Sofamor Danek USA Inc recalls INFUSE(R) Bone Graft,LARGE II KIT, REF 7510800, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tenness
Hazard: Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.
July 3, 2013Medical DevicesFDA
Medtronic Sofamor Danek USA Inc recalls INFUSE(R) Bone Graft, LARGE KIT, REF 7510600, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee
Hazard: Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.
July 3, 2013Medical DevicesFDA
Medtronic Sofamor Danek USA Inc recalls INFUSE(R) Bone Graft, MEDIUM KIT, REF 7510400, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennesse
Hazard: Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.
July 3, 2013Medical DevicesFDA
Medtronic Sofamor Danek USA Inc recalls INFUSE(R) Bone Graft, SMALL KIT, REF 7510200, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee
Hazard: Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.
October 17, 2012Medical DevicesFDA
Medtronic Sofamor Danek USA Inc recalls PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, I
Hazard: Lines on the screw gauge may not placed on the caddy properly which could result in improper measurement of screws. An incorrect gauge could measure a screw to be approximately 1 mm shorter than its actual length.
October 17, 2012Medical DevicesFDA
Medtronic Sofamor Danek USA Inc recalls ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-504, QTY: 1 EA, Rx only, Medtronic Sofamor
Hazard: Lines on the screw gauge may not placed on the caddy properly which could result in improper measurement of screws. An incorrect gauge could measure a screw to be approximately 1 mm shorter than its actual length.
October 17, 2012Medical DevicesFDA
Medtronic Sofamor Danek USA Inc recalls ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 176-503, QTY: 1 EA, Rx only, Medtronic Sofa
Hazard: Lines on the screw gauge may not placed on the caddy properly which could result in improper measurement of screws. An incorrect gauge could measure a screw to be approximately 1 mm shorter than its actual length.