Manufacturer
85 recalls in our database name Medtronic Sofamor Danek USA, Inc as the manufacturing or recalling firm.
Of the 85 recalls from Medtronic Sofamor Danek USA, Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (1%) are Severe.
The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.
Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.
Medtronic is recalling 138 units of INFUSE Bone Graft X Small Kits because they may contain two absorbable collagen sponges instead of one.
Medtronic is recalling 47 CD HORIZON Spinal System screws because they are incorrectly laser marked as 5.5 mm diameter when they are actually 5.0 mm.
Medtronic is recalling specific drill guides for the Prestige LP Cervical Disc System because they may cause drill bits to break during use.
Medtronic is recalling 39 ZEVO Anterior Cervical Plate System slot screws because they are 15mm long instead of the specified 17mm.
Medtronic is recalling two units of the ANGLED DRILL (REF 6630902) because the drill tip extension is longer than the printed specification indicates.
Medtronic is recalling KYPHON Express Directional Bone Filler Devices because the directional arrow may not align with the opening.
Medtronic is recalling KYPHON Directional Bone Filler Devices because the directional arrow may not align with the opening, potentially causing cement to be placed in an unintended direction.
Medtronic is recalling 36 units of PAK Needle Beveled and Trocar Tips because packaging may contain incorrect needle types instead of the required combination.
Medtronic is recalling Poly Component Trial knee implants because the dovetails were observed as cracked or broken.
Medtronic is recalling 111 units of Poly Component Trials because the dovetails were observed as cracked or broken.
Medtronic is recalling 72 Poly Component Trial knee implants because their dovetails were observed as cracked or broken.
Medtronic Sofamor Danek USA Inc is recalling 72 units of Poly Component Trial knee implants because the dovetails were observed as cracked or broken.
Medtronic is recalling three units of Alpha total knee replacement femoral components because they may not have been passivated according to job traveler requirements.
Medtronic is recalling specific Alpha total knee replacement tibial trays that may not have been passivated according to manufacturing requirements.
Medtronic is recalling two units of Alpha total knee replacement tibial trays that may not have been passivated according to job traveler requirements.
Medtronic is recalling three units of tibial tray components for total knee replacement because they may not have been passivated correctly.
Medtronic Sofamor Danek USA Inc is recalling four units of Alpha total knee replacement femoral components that may not have been passivated according to requirements.
Medtronic Sofamor Danek is recalling specific total knee replacement femoral components that may not have been passivated correctly.
Medtronic is recalling three units of tibial tray components for total knee replacement because they may not have been passivated according to requirements.
Medtronic is recalling Alpha total knee replacement femoral components that may not have been passivated according to job traveler requirements.
Medtronic is recalling 239 units of the KYPHON EXPRESS Osteo Introducer System because the packaging may contain the wrong instrument tips.
Medtronic is recalling 24 units of the POWEREASE Set Screw Breakoff Instrument because oversized retaining tabs may prevent proper mating with the set screw.
Medtronic is recalling GRAFTON DBM Flex units labeled as 2.5 cm x 10 cm that actually measure 2.5 cm x 5 cm.
Medtronic is recalling seven Set Screw Retaining Drivers because oversized retaining tabs may prevent proper mating with set screws.
Medtronic is recalling nine T8 Removal Heads used in spinal surgery due to incorrect hardness specifications that could cause the tool to fail during implant removal.