MeridianRecalls & reported problems across all models

We found 8 models of Meridian by Seaspine Orthopedics Corporation in the FDA's device registry (GUDID). Together they are named in 8 adverse event reports in the FDA's MAUDE database, received between Apr 5, 2021 and Jun 4, 2026 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Positioning” (1 report).

1 FDA recall record name at least one of these models by its device identifier, 1 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

Meridian 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.

1. Jun 4, 2024Open, Classified

   Insufficient weld around the cap component of the instrument is insufficient to withstand impaction forces.

   Z-2357-2024 · Root cause: Process design · Recall details · FDA record ↗

Most reported Meridian problems

Meridian models

8 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Meridian RA2-003015

  AWL
  1 recall1 report
• Meridian RA1-211210

  Intervertebral fusion device with bone graft, lumbar
  1 report
• Meridian RA1-250000

  Intervertebral fusion device with integrated fixation, lumbar
  1 report
• Meridian RA2-001003

  Intervertebral fusion device with integrated fixation, lumbar
  1 report
• Meridian RA2-003020

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  1 report
• Meridian RA2-004002

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  1 report
• Meridian RA2-006014

  Orthopedic manual surgical instrument
  1 report
• Meridian RA1-504315

  Intervertebral fusion device with integrated fixation, lumbar
  1 report

Recent Meridian adverse event reports

The 8 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2026Mechanical Problem

  ON (B)(6) 2026, DURING A SPINAL FUSION PROCEDURE, THE REPORTER EXPERIENCED DIFFICULTY USING A MODULAR PLATE COMPRESSOR TO SECURE A PLATE TO AN IMPLANT. MULTIPLE ATTEMPTS WERE MADE USING ADDITIONAL IMPLANTS AND PLATES; HOWEVER, THE CONDITION PERSISTED. AN ALTERNATE INSTRUMENT FROM A DIFFERENT INSTRUMENT SET WAS OBTAINED AND SUCCESSFULLY USED TO COMPLETE THE PROCEDURE. THE EVENT REPORTEDLY RESULTED IN AN APPROXIMATE 30-MINUTE SURGICAL DELAY, PROMPTING THIS REPORT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO REPORTED PATIENT INJURY OR ADVERSE CLINICAL OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25394810 ↗
• MalfunctionDec 17, 2025Material Fragmentation; Material Fragmentation

  ON (B)(6) 2025, A SURGEON EXPERIENCED ISSUES WHEN USING THE MERIDIAN STRAIGHT DRIVER. WHEN IMPLANTING A SCREW, THE TIP OF THE MERIDIAN STRAIGHT DRIVER FRACTURED OFF. ALTHOUGH THE SURGEON ATTEMPTED TO RETRIEVE THE TIP FROM THE SCREW HEAD, IT WAS UNABLE TO BE REMOVED AND THE SCREW REMAINED IMPLANTED WITH THE FRACTURED TIP INSIDE. NO PATIENT INJURIES WERE REPORTED AND NO ADDITIONAL MEDICAL OR SURGICAL TREATMENT WAS REQUIRED. ADDITIONALLY, THE REP CONFIRMED THE ISSUE DID NOT CAUSE A DELAY IN THE SURGICAL PROCEDURE. THE SURGERY WAS ABLE TO BE COMPLETED WITH A BACK-UP MERIDIAN STRAIGHT DRIVER.

  Patient problems: Foreign Body In Patient

  MAUDE report 23832707 ↗
• MalfunctionJul 8, 2025Migration; Migration

  ON 18 JUN 2025, SEASPINE/ORTHOFIX WAS MADE AWARE OF RA1-250000 NO-PROFILE LOCKING COVER THAT HAD BACKED OUT OF A WAVEFORM A NO-PROFILE CAGE CONSTRUCT. THE ISSUE WAS OBSERVED APPROXIMATELY THREE WEEKS AFTER THE INDEX SURGERY. THE EXACT DATE OF IMPLANTATION IS UNKNOWN. THE PROVIDED X-RAY CORROBORATES THE REPORT. NO PATIENT INJURY WAS REPORTED, AND NO REVISION SURGERY IS PLANNED CURRENTLY.

  Patient problems: Insufficient Information

  MAUDE report 22438809 ↗
• MalfunctionSep 5, 2024Difficult to Advance; Difficult to Advance

  ON (B)(6) 2024, A PATIENT UNDERWENT SPINAL SURGERY UTILIZING SEASPINE'S MERIDIAN ANTERIOR LUMBAR INTERBODY SYSTEM. IT WAS REPORTED THAT THE SURGEON HAD DIFFICULTY SEATING THE SCREWS INTO THE 4-HOLE INTERBODIES, RESULTING IN A 30-45 MINUTE SURGICAL DELAY. IMPLANTED SCREWS WERE SUCCESSFULLY PLACED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20146295 ↗
• MalfunctionApr 23, 2024Material Integrity Problem; Material Integrity Problem

  ON (B)(6) 2024, A PATIENT UNDERWENT SPINAL SURGERY WITH SEASPINE'S MERIDIAN INTERBODY SYSTEM. SEASPINE RECEIVED A COMPLAINT REGARDING THE MERIDIAN ANGLED AWL FIXED. DURING SCREW PLACEMENT, THE WELD OF THE ANGLED AWL FRACTURED, WHICH SUBSEQUENTLY PREVENTED THE IMPLANTATION OF THE 2 L5 SCREWS BECAUSE THE STRAIGHT AWL COULD NOT ACHIEVE THE REQUIRED ANGLE. AS A RESULT, THE SURGEON PROCEEDED WITH ONLY 1 SCREW IN S1 AND NO L5 FIXATION, OPTING TO USE PERCUTANEOUS PEDICLE SCREWS POSTERIORLY INSTEAD, LEADING TO A 30-MINUTE PROCEDURAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19168538 ↗
• MalfunctionNov 1, 2022Fracture; Fracture

  ON (B)(6) 2022 THE PATIENT UNDERWENT SPINAL SURGERY UTILIZING SEASPINE'S MERIDIAN ANTERIOR LUMBAR INTERBODY SYSTEM. DURING SURGERY, THE TIP OF THE RA2-004002 LOCKING COVER DRIVER BROKE OFF INTO THE PLATE IT WAS SECURING. THE TIP WAS UNABLE TO BE RETRIEVED. THE SURGEON WAS NOT CONCERNED, AND NO REVISION SURGERY IS PLANNED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15710269 ↗
• InjuryApr 15, 2021Difficult or Delayed Positioning; Difficult to Remove; Difficult or Delayed Positioning; Difficult to Remove

  ON (B)(6) 2021, THE PATIENT UNDERWENT SINGLE-LEVEL (L5-S1) ALIF SPINAL SURGERY CONSISTING OF SEASPINE'S MERIDIAN SYSTEM. DURING THE SURGERY, THE SURGEON ATTEMPTED TO PLACE A STAND-ALONE, NO- PROFILE INTERBODY, WHICH FEATURED TWO DOWNWARD ANCHORS AND ONE UPWARD SCREW. THE SURGEON DETERMINED THE PLACEMENT WAS NOT IDEAL, AND ATTEMPTED TO REMOVE THE ANCHOR TO ALLOW FOR REPOSITIONING, CREATING A BONE VOID DURING THE REMOVAL PROCESS. THE BONE VOID WAS TOO LARGE TO ACCOMMODATE ANY TYPE OF FIXATION IN THAT LOCATION, SO THE SURGEON COMPLETED THE CASE BY PLACING ONE DOWNWARD SCREW. THE FINAL CONSTRUCT CONSISTED OF A THREE-HOLE STAND-ALONE, NO-PROFILE INTERBODY FIXATED BY ONE UPWARD SCREW AND ONE DOWNWARD SCREW, WITH A VOID AT THE THIRD HOLE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11675881 ↗
• InjuryApr 5, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  ON (B)(6) 2021, THE PATIENT UNDERWENT L3-L5 ALIF SPINAL SURGERY USING THE SEASPINE MERIDIAN SYSTEM. DURING SURGERY, THE INTERBODY INSERTER WOULD NOT DISENGAGE FROM THE INTERBODY, NECESSITATING REMOVAL OF THE INTERBODY. BECAUSE OF THIS A VESSEL WAS NICKED, CAUSING SIGNIFICANT BLEEDING. THE VASCULAR SURGEON HAD TO INTERVENE TO PREVENT FURTHER BLEEDING. THE CASE WAS COMPLETED WITH NO ADDITIONAL INTERVENTION NEEDED. THE PATIENT HAS NOT EXPERIENCED ANY POST OPERATIVE COMPLICATIONS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation of Vessels

  MAUDE report 11614886 ↗

Other Seaspine Orthopedics Corporation products

• Mariner15 models · 147 reports · 1 recall
• Daytona Small Stature3 models · 14 reports · 2 recalls
• Fathom3 models · 2 reports · 2 recalls
• NorthStar24 models · 15 reports · 1 recall
• Mariner Deformity3 models · 2 reports · 1 recall
• Virata25 models · 0 reports · 1 recall
• Reef TA2 models · 0 reports · 1 recall
• Mariner RDX6 models · 0 reports · 1 recall