INFINITY Occipitocervical Upper Thoracic SystemRecalls & reported problems across all models
Medtronic Sofamor Danek, Inc. · 35 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
5 open recalls name at least one INFINITY Occipitocervical Upper Thoracic System model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 63
- Deaths reported
- 0
- Injuries reported
- 33
- Recalls
- 5
We found 35 models of INFINITY Occipitocervical Upper Thoracic System by Medtronic Sofamor Danek, Inc. in the FDA's device registry (GUDID). Together they are named in 63 adverse event reports in the FDA's MAUDE database, received between Feb 26, 2020 and Jul 6, 2026 — classified as 33 injuries, 30 malfunctions.
The most frequently reported specific device problem is “Break” (14 reports).
5 FDA recall records name at least one of these models by its device identifier, 5 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
INFINITY Occipitocervical Upper Thoracic System recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Feb 16, 2023Open, Classified
Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws
Z-1413-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Feb 16, 2023Open, Classified
Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws
Z-1412-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Feb 16, 2023Open, Classified
Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws
Z-1411-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Feb 16, 2023Open, Classified
Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws
Z-1410-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Feb 16, 2023Open, Classified
Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws
Z-1409-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported INFINITY Occipitocervical Upper Thoracic System problems
Device problems
- Break14
- Material Deformation13
- Migration11
- Device Dislodged or Dislocated10
- Loosening of Implant Not Related to Bone-Ingrowth4
- Use of Device Problem4
- Device Damaged by Another Device2
- Mechanics Altered2
Patient problems
- No Clinical Signs, Symptoms or Conditions31
- No Known Impact Or Consequence To Patient10
- Pain7
- Injury6
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Hemorrhage/Blood Loss/Bleeding2
- Neck Pain2
- Spinal Column Injury2
INFINITY Occipitocervical Upper Thoracic System models
35 models, most reported first. Each model has its own page with its reports, recalls and device details.
- INFINITY™ Occipitocervical Upper Thoracic System 3604026Orthosis, cervical pedicle screw spinal fixation2 recalls1 report
- INFINITY™ Occipitocervical Upper Thoracic System 3604532Orthosis, cervical pedicle screw spinal fixation1 recall0 reports
- INFINITY™ Occipitocervical Upper Thoracic System 360PT4022Orthosis, cervical pedicle screw spinal fixation1 recall0 reports
- INFINITY™ Occipitocervical Upper Thoracic System 3604024Orthosis, cervical pedicle screw spinal fixation1 recall0 reports
- INFINITY™ Occipitocervical Upper Thoracic System 3600315APPLIANCE, FIXATION, SPINAL INTERLAMINAL8 reports
- INFINITY™ Occipitocervical Upper Thoracic System G3605525Orthosis, cervical pedicle screw spinal fixation6 reports
- INFINITY™ Occipitocervical Upper Thoracic System 3604012Orthosis, cervical pedicle screw spinal fixation6 reports
- INFINITY™ Occipitocervical Upper Thoracic System 3600215APPLIANCE, FIXATION, SPINAL INTERLAMINAL4 reports
- INFINITY™ Occipitocervical Upper Thoracic System G3600215APPLIANCE, FIXATION, SPINAL INTERLAMINAL4 reports
- INFINITY™ Occipitocervical Upper Thoracic System G3603514APPLIANCE, FIXATION, SPINAL INTERLAMINAL3 reports
- INFINITY™ Occipitocervical Upper Thoracic System 3603514APPLIANCE, FIXATION, SPINAL INTERLAMINAL3 reports
- INFINITY™ Occipitocervical Upper Thoracic System 3602536APPLIANCE, FIXATION, SPINAL INTERLAMINAL2 reports
- INFINITY™ Occipitocervical Upper Thoracic System G3603522Orthosis, cervical pedicle screw spinal fixation2 reports
- INFINITY™ Occipitocervical Upper Thoracic System G3603524APPLIANCE, FIXATION, SPINAL INTERLAMINAL2 reports
- INFINITY™ Occipitocervical Upper Thoracic System G3602550Orthosis, cervical pedicle screw spinal fixation2 reports
- INFINITY™ Occipitocervical Upper Thoracic System 3600600APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- INFINITY™ Occipitocervical Upper Thoracic System 3602526APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- INFINITY™ Occipitocervical Upper Thoracic System G3605535APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- INFINITY™ Occipitocervical Upper Thoracic System G3604512Orthosis, cervical pedicle screw spinal fixation1 report
- INFINITY™ Occipitocervical Upper Thoracic System 3604522APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- INFINITY™ Occipitocervical Upper Thoracic System G360PT3532Orthosis, cervical pedicle screw spinal fixation1 report
- INFINITY™ Occipitocervical Upper Thoracic System G3603512Orthosis, cervical pedicle screw spinal fixation1 report
- INFINITY™ Occipitocervical Upper Thoracic System G3603518APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- INFINITY™ Occipitocervical Upper Thoracic System G3603528APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- INFINITY™ Occipitocervical Upper Thoracic System G3603532APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- INFINITY™ Occipitocervical Upper Thoracic System G3600600Orthosis, cervical pedicle screw spinal fixation1 report
- INFINITY™ Occipitocervical Upper Thoracic System G3602536Orthosis, cervical pedicle screw spinal fixation1 report
- INFINITY™ Occipitocervical Upper Thoracic System G3602537Orthosis, cervical pedicle screw spinal fixation1 report
- INFINITY™ Occipitocervical Upper Thoracic System 360PT3528Orthosis, cervical pedicle screw spinal fixation1 report
- INFINITY™ Occipitocervical Upper Thoracic System 3603518Orthosis, cervical pedicle screw spinal fixation1 report
- INFINITY™ Occipitocervical Upper Thoracic System G360T0408APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- INFINITY™ Occipitocervical Upper Thoracic System G360T0410Orthosis, cervical pedicle screw spinal fixation1 report
- INFINITY™ Occipitocervical Upper Thoracic System G360T0412Orthosis, cervical pedicle screw spinal fixation1 report
- INFINITY™ Occipitocervical Upper Thoracic System G360T0414APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- INFINITY™ Occipitocervical Upper Thoracic System G3600216APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
Recent INFINITY Occipitocervical Upper Thoracic System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJul 6, 2026Device Dislodged or Dislocated
ON (B)(6) 2026 MPXR (B)(4) (REP, HCP, FOR): INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING REOPERATION C1/2 POSTERIOR FIXATION, BONE GRAFTING FOR C1 INSTABILITY DUE TO TRAUMA. IT WAS REPORTED THAT PATIENT HAD POSTOPERATIVE SET-SCREW DISLODGEMENT. THE RIGHT C1 SET SCREW DISENGAGED POSTOPERATIVELY, AND LOOSENING OF THE RIGHT SCREW (C1/2) WAS CONFIRMED; THEREFORE, THE SIZE WAS CHANGED AND REFIXATION WAS PERFORMED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25713634 ↗MalfunctionJul 2, 2026No Apparent Adverse Event
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT, THE ROD AND SET SCREW WAS LOOSENED AT T1 LEVEL POST-OPERATIVELY. PATIENT EXPERIENCED NECK PAIN, AND COULD HEAR SQUEAKING WHEN MOVING NECK. SQUEAKING SENSATION UP TO HER SKULL. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED STATING PROCEDURE PERFORMED WAS C4 - T1 POSTERIOR EXTENSION OF FUSION. MAS WERE INTACT, NO FAILURE ASSOCIATED WITH MAS SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25688650 ↗MalfunctionApr 22, 2026Break
INFORMATION WAS OBTAINED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A SCREW BEING USED FOR POSTERIOR SPINAL FIXATION (INCLUDING THE OCCIPITAL BONE) IN A PATIENT WITH THE PRE-OPERATIVE DIAGNOSIS OF AXIAL FRACTURE. THE SCREW WAS BEING IMPLANTED IN THE OCCIPITAL BONE BUT WHEN THE SCREW TIP WAS SLIGHTLY INSERTED INTO THE PATIENT AND THEN WITHDRAWN ONCE, DEFORMATION OR CHIPPING OF THE SCREW WAS OBSERVED. PATIENT INVOLVED DID NOT EXPERIENCE ANY SYMPTOMS AS A CONSEQUENCE OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED STATED THAT THE PROCEDURE INVOLVED IN THE EVENT WAS POSTERIOR CERVICAL FIXATION INCLUDING THE OCCIPITAL BONE. THE EVENT OCCURRED DURING FIXATION WITH SCREWS FOR THE OCCIPITAL PLATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24951881 ↗MalfunctionSep 2, 2025Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE DEVICE SHEARED OFF THROUGH THE MIDDLE WHEN THE CENTRAL NUT WAS BEING TORQUED OFF, AFTER BOTH DISTAL SET SCREWS WERE SEATED AND LOCKED OFF. THERE WERE NO BROKEN FRAGMENTS LEFT INSIDE THE PATIENT AND NO PATIENT COMPLICATIONS OR SYMPTOMS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE PRE-OP DIAGNOSIS OF PATIENT WAS CERVICAL DEGENERATIVE DISC DISEASE, PROCEDURE INVOLVED IN THE EVENT WAS POSTERIOR CERVICAL SPINAL FUSION FOR STABILIZING, LEVEL IMPLANTED WAS C3-7. PROCEDURE WAS COMPLETED BY REPLACING ANOTHER SAME DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22932348 ↗MalfunctionAug 25, 2025Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED POST C3-C6 POSTERIOR CERVICAL FIXATION PROCEDURE WITH DECOMPRESSION IN A PATIENT WITH MEDICAL HISTORY OF NECK PAIN AND DIFFICULTY IN WALKING AND INABILITY TO HOLD ANYTHING WELL WITH HIS ARM. IT WAS REPORTED THAT 2 MONTH AFTER SURGERY, PATIENT VISITED THE CLINIC WITH WEAKNESS IN HIS ARM. PATIENT HAD MORE WEAKNESS IN HIS HAND AND SURGEON EXPECT THIS FROM BROKEN SCREW. PATIENT DID NOT ACHIEVE FUSION 2 MONTH POST SURGERY. NO PLAN TO EXPLANT THE SCREW. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Muscle Weakness/Atrophy
MAUDE report 22881849 ↗InjuryAug 14, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING C3-TH1 POSTERIOR FIXATION THERAPY FOR C5/6 FRACTURE. IT WAS REPORTED THAT THE SET SCREW DETACHED TWO WEEKS AFTER SURGERY WITHOUT CAUSING SYMPTOMS. SUBSEQUENT MONITORING REVEALED TWO ADDITIONAL DISLODGEMENTS, LEADING TO A PLANNED REPEAT SURGERY (ON (B)(6) 2025). THE PHYSICIAN ATTRIBUTED THE ISSUE TO A PRODUCT DEFECT, NOT MISUSE. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. RE-OPERATION FOR REPLACING THE ROD AND SET SCREW WAS PERFORMED. EVEN THE PART WHERE THE SET SCREW WAS NOT LOOSENED COULD BE REMOVED EASILY (WITHOUT APPLYING MORE FORCE THAN USUAL). REOPERATION WAS PERFORMED DUE TO SET SCREW DISLODGEMENT AFTER THE INITIAL SURGERY OF (B)(6) 2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22809150 ↗InjuryAug 14, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THERE WERE TOTALLY 8 PRODUCTS WERE INVOLVED IN THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22809127 ↗InjuryAug 14, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THERE WERE TOTALLY 8 PRODUCTS WERE INVOLVED IN THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22809108 ↗InjuryJul 2, 2025Use of Device Problem; Malposition of Device; Use of Device Problem; Malposition of Device
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT HAVING SPINAL THERAPY FOR CERVICAL FRACTURE. IT WAS REPORTED THAT DURING A C2-C7 SPINAL FIXATION PROCEDURE, A POTENTIAL MISALIGNMENT OF THE NAVIGATION SYSTEM (O-ARM) RESULTED IN THE LEFT PEDICLE SCREW AT C4 BEING MISPLACED BY 5 MM OR MORE, POSING A RISK OF VERTEBRAL ARTERY (VA) DAMAGE. DUE TO THE HIGH RISK OF HEMORRHAGING IF REPOSITIONED, THE SURGICAL TEAM DECIDED TO LEAVE THE SCREW IN PLACE AND PROCEEDED WITH WOUND CLOSURE. POST-OPERATIVELY, THE PATIENT DID NOT REGAIN CONSCIOUSNESS AND WAS TRANSFERRED TO THE WARD. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Loss of consciousness
MAUDE report 22381682 ↗MalfunctionMay 15, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR CERVI CAL C4-T3. IT WAS REPORTED THAT A SET SCREW WAS FOUND IN A X-RAY OF THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT AN INFINITY SET SCREW IS VISIBLE ON AN X-RAY NOT IN THE TULIP OF A SCREW. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WAS NO ADDITIONAL SURGERY PERFORMED AND AT THIS TIME NO ADDITIONAL SURGERY IS PLANNED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22025756 ↗MalfunctionApr 21, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER, CLINICAL STUDY VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT OCCURRED POST-OPERATIVELY. IT WAS REPORTED THAT, THE SCREW WAS LOOSENED FROM CONSTRUCT AT T1 (THORACIC VERTEBRAE) AND WAS CAUSING PAIN. PROCEDURE/TECHNIQUE PERFORMED WAS POSTERIOR SPINAL FIXATION & FUSION (C2- T1). THE EVENT WAS IDENTIFIED IN ROUTINE CLINIC VISIT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: Pain
MAUDE report 21871065 ↗MalfunctionMar 31, 2025Material Deformation; Material Deformation
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR CERVI CAL/THORACIC FIXATION AT C4-T2 FOR CERVICAL CORD COMPRESSION. IT WAS REPORTED THAT THE FEMALE COMPONENT OF THE IMPLANT ROUNDED OFF WHILST FINISHING IMPLANTATION. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21735879 ↗InjuryMar 26, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
ADDITIONAL INFORMATION RECEIVED: PER SURGEON'S PROCEDURE NOTE, THERE WAS A SMALL AMOUNT OF DARK STAINING ADJACENT TO THE T10 ROD CONNECTORS SUGGESTIVE OF METALLOSIS WHICH WOULD BE CONSISTENT WITH MECHANICAL LOOSENING. THERE WAS NO OBVIOUS METALLOSIS AT THE T5-T7 REGIONS WHERE THE ACCESSORY RODS WERE LOCATED. AT THE CERVICO THORACIC JUNCTION ONE OF THE RIGHT SIDED CERVICAL-THORACIC RODS WAS NOT GROSSLY LOOSE BUT WITH GRASPING IT WITH HEAVY NEEDLE DRIVER COULD ROTATE THE CONNECTOR WHICH ALSO DEMONSTRATED MECHANICAL LOOSENING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21695445 ↗MalfunctionMar 20, 2025Use of Device Problem; Use of Device Problem
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT UNDERGOING POSTERIOR CERVICAL FUSION AT LEVELS C1-3 FOR C1, C2 FRACTURE. IT WAS REPORTED THAT THE 28MM RIGHT C1 SCREW WAS SHORTER AND WAS NOT TOUCHING THE TIP OF THE SCREW IN THE FRACTURE LINE WHEN INSERTING, SO IT WAS CHANGED TO 30 MM. THERE WAS A DELAY OF LESS THAN 60 MINUTES. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21650419 ↗MalfunctionMar 12, 2025Material Twisted/Bent; Material Twisted/Bent
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING C3-4 LMS, C6-7 PS POSTERIOR FIXATION (2A-2B) FOR C5 FRACTURE DUE TO FALL INJURY. IT WAS REPORTED THAT THE SCREW WAS PREPARED FOR LMS PLACEMENT, AND WHEN IT WAS TRIED TO PLACE IT ON A SCREWDRIVER, THE SCREW OF THE PRODUCT DID NOT FIT STRAIGHT INTO THE SCREWDRIVER. IT DID NOT FIT AND WAS PLACED ASKEW/IN A SLANTED ANGLE NO MATTER HOW MANY ATTEMPTS WERE MADE, SO IT WAS REPLACED WITH A PRODUCT OF THE SAME MODEL NUMBER AND SIZE. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21581589 ↗
Other Medtronic Sofamor Danek, Inc. products
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- GRAFTONand GRAFTON PLUSDemineralized Bone Matrix (DBM)25 models · 12 reports · 14 recalls
- METRx System5 models · 672 reports
- INFUSE Bone Graft6 models · 576 reports · 1 recall
- CD HORIZON SOLERA VOYAGER Spinal System60 models · 411 reports
- POWEREASE Instruments8 models · 331 reports · 1 recall
- Catalyft PL Expandable Interbody System16 models · 279 reports · 1 recall
- Catalyft LS Expandable Interbody System6 models · 3 reports · 6 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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