Medtronic Sofamor Danek Usa recalls
Medtronic Sofamor Danek Usa appears in 85 official U.S. recall notices indexed by RecallRadar.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- INFUSE Bone Graft X SMALL KIT REF 7510100
FDA Device · Class II · 2018-11-21 · Medtronic Sofamor Danek Usa
Reason: The Extra Small INFUSE Bone Graft kit from lot M111806AAA, may contain two absorbable collagen sponges (ACS), but should only contain one ACS. - Medtronic CD HORIZON Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion…
FDA Device · Class II · 2018-08-15 · Medtronic Sofamor Danek Usa
Reason: This lot has incorrectly been laser marked both on the screw head itself as well as the data carrier tag attached to the screw. The description on face two of the screw head and on the data carrier tag both incorrectly… - Medtronic ZEVO(TM) Anterior Cervical Plate System SLOT SCREW, REF 7710015, Size 4.5mm x 15mm Product Appliance, fixation, spinal interverte…
FDA Device · Class II · 2018-05-16 · Medtronic Sofamor Danek Usa
Reason: Slot screw had an overall length of 15mm, but per the specification, the screw should have an overall length of approximately 17mm. - Medtronic Prestige LP(TM) Cervical Disc System with Streamlined Instruments, DRILL GUIDES: a) REF 6975205, 5mm b) REF 6975206, 6mm c) REF 6…
FDA Device · Class II · 2018-05-16 · Medtronic Sofamor Danek Usa
Reason: The firm received complaints of drill bits breaking during use with the Prestige LP(TM) Cervical Disc System. Subsequent investigation demonstrated the interaction of the drill guide and the drill bit may lead to drill… - Medtronic ANGLED DRILL, REF 6630902, QTY: 1 EA Rx only
FDA Device · Class II · 2018-02-21 · Medtronic Sofamor Danek Usa
Reason: Medtronic has discovered the product lot in question was noted as having a longer drill tip extension than what is indicated on the print specification. - Medtronic KYPHON(R) Express(TM) Directional Bone Filler Device, SIZE 2, REF FB, QTY 1 EA, Rx only STERILE R
FDA Device · Class II · 2018-01-24 · Medtronic Sofamor Danek Usa
Reason: Medtronic has discovered the directional arrow at the proximal end of the instrument may not correctly align with the cut out opening on the distal end of the instrument. - KYPHON(R) Directional Bone Filler Device, Size: 3, REF F04C, Rx Only, STERILE R
FDA Device · Class II · 2017-06-14 · Medtronic Sofamor Danek Usa
Reason: The directional arrow at the proximal end of the instrument may not correctly align with the cutout opening on the distal end of the instrument. Using affected bone void filler may result in the injected cement being p… - Medtronic PAK NEEDLE BEVELED AND TROCAR TIPS, REF 8670009, QTY 1 EA, STERILE R, Rx only
FDA Device · Class II · 2017-05-17 · Medtronic Sofamor Danek Usa
Reason: Product packaging may incorrectly include two bevel-tipped needles or two trocar-tipped needles instead of one diamond-tipped needle and one bevel-tipped needle. - Poly Component Trial, CR, packaged in the following sizes and configurations: a) Poly Component Trial - CR 3x10, REF 90-SRK-160310 b) Poly…
FDA Device · Class II · 2017-03-29 · Medtronic Sofamor Danek Usa
Reason: The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken. - Poly Component Trial, UCCS, packaged in the following sizes and configurations: a) Poly Comp Trial - UCCS 3x10, REF 90-SRK-170310 b) Poly C…
FDA Device · Class II · 2017-03-29 · Medtronic Sofamor Danek Usa
Reason: The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken. - Poly Component Trial, MPCS, packaged in the following sizes and configurations: a) Poly Component Trial - MPCS 3x10L, REF 90-SRK-192310 b)…
FDA Device · Class II · 2017-03-29 · Medtronic Sofamor Danek Usa
Reason: The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken. - Poly Component Trial, PS, packaged in the following sizes and configurations: a) Poly Component Trial - PS 3x10, REF 90-SRK-180310 b) Poly…
FDA Device · Class II · 2017-03-29 · Medtronic Sofamor Danek Usa
Reason: The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken. - RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 3L, REF 90-SRK-312300, QTY: 1, STERILE R
FDA Device · Class II · 2016-08-31 · Medtronic Sofamor Danek Usa
Reason: The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler. - RESPONSIVE, KNEE: FEMORAL COMPONENT CR/CS, SIZE 3R, REF 90-SRK-311300, QTY: 1, STERILE R
FDA Device · Class II · 2016-08-31 · Medtronic Sofamor Danek Usa
Reason: The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler. - RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 4R, REF 90-SRK-311400, QTY: 1, STERILE R
FDA Device · Class II · 2016-08-31 · Medtronic Sofamor Danek Usa
Reason: The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler. - TIBIAL TRAY , SIZE 2, REF 90-SRK-200200, QTY: 1, STERILE R, total knee replacement
FDA Device · Class II · 2016-08-31 · Medtronic Sofamor Danek Usa
Reason: The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler. - TIBIAL TRAY , SIZE 5, REF 90-SRK-200500, QTY: 1, STERILE R, Responsive Orthopedics, total knee replacement
FDA Device · Class II · 2016-08-31 · Medtronic Sofamor Danek Usa
Reason: The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler. - RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 5R, REF 90-SRK-311500, QTY: 1, STERILE R
FDA Device · Class II · 2016-08-31 · Medtronic Sofamor Danek Usa
Reason: The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler. - TIBIAL TRAY , SIZE 4, REF 90-SRK-200400, QTY: 1, STERILE R, Responsive Orthopedics, total knee replacement
FDA Device · Class II · 2016-08-31 · Medtronic Sofamor Danek Usa
Reason: The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler. - TIBIAL TRAY , SIZE 3, REF 90-SRK-200300, QTY: 1, STERILE R, total knee replacement
FDA Device · Class II · 2016-08-31 · Medtronic Sofamor Danek Usa
Reason: The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler. - KYPHON EXPRESS, Osteo Introducer System, Diamond and Bevel, Size 2, REF T34A, QTY: 1EA, Rx only, STERILE R. For use with spinal fixation de…
FDA Device · Class II · 2015-02-11 · Medtronic Sofamor Danek Usa
Reason: 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. - POWEREASE Instruments Set Screw Breakoff Instrument, REF 2346010, Medtronic Sofamor Danek, USA, Inc
FDA Device · Class II · 2015-01-21 · Medtronic Sofamor Danek Usa
Reason: 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. - 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 P…
FDA Device · Class II · 2014-02-19 · Medtronic Sofamor Danek Usa
Reason: 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. - SET SCREW RETAINING DRIVER, REF 9010000820, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc
FDA Device · Class II · 2014-02-05 · Medtronic Sofamor Danek Usa
Reason: 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. - 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…
FDA Device · Class II · 2013-09-25 · Medtronic Sofamor Danek Usa
Reason: 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 t… - INFUSE(R) Bone Graft,LARGE II KIT, REF 7510800, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
FDA Device · Class II · 2013-07-03 · Medtronic Sofamor Danek Usa
Reason: Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation. - INFUSE(R) Bone Graft, SMALL KIT, REF 7510200AUS, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaed…
FDA Device · Class II · 2013-07-03 · Medtronic Sofamor Danek Usa
Reason: Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation. - INFUSE(R) Bone Graft, LARGE II KIT, REF 7510800AUS, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthop…
FDA Device · Class II · 2013-07-03 · Medtronic Sofamor Danek Usa
Reason: Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation. - INFUSE(R) Bone Graft, LARGE KIT, REF 7510600, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
FDA Device · Class II · 2013-07-03 · Medtronic Sofamor Danek Usa
Reason: Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation. - INFUSE(R) Bone Graft, MEDIUM KIT, REF 7510400AUS, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopae…
FDA Device · Class II · 2013-07-03 · Medtronic Sofamor Danek Usa
Reason: Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation. - INFUSE(R) Bone Graft, SMALL KIT, REF 7510200, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
FDA Device · Class II · 2013-07-03 · Medtronic Sofamor Danek Usa
Reason: Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation. - INFUSE(R) Bone Graft, MEDIUM KIT, REF 7510400, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
FDA Device · Class II · 2013-07-03 · Medtronic Sofamor Danek Usa
Reason: Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation. - PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Pl…
FDA Device · Class II · 2012-10-17 · Medtronic Sofamor Danek Usa
Reason: 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. - ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 176-503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc.…
FDA Device · Class II · 2012-10-17 · Medtronic Sofamor Danek Usa
Reason: 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. - ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-504, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1…
FDA Device · Class II · 2012-10-17 · Medtronic Sofamor Danek Usa
Reason: 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.