MectaLIF AnteriorRecalls & reported problems across all models
Medacta International SA · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 6
We found 6 models of MectaLIF Anterior by Medacta International SA in the FDA's device registry (GUDID). Together they are named in 4 adverse event reports in the FDA's MAUDE database, received between Mar 9, 2023 and Oct 30, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Fracture” (4 reports).
6 FDA recall records name at least one of these models by its device identifier.
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
MectaLIF Anterior 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.
- Mar 8, 2023Completed
There is a potential for breakage of the small screw used to affix the anti-backout plate.
Z-1405-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Mar 8, 2023Completed
There is a potential for breakage of the small screw used to affix the anti-backout plate.
Z-1404-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Mar 8, 2023Completed
There is a potential for breakage of the small screw used to affix the anti-backout plate.
Z-1403-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Mar 8, 2023Completed
There is a potential for breakage of the small screw used to affix the anti-backout plate.
Z-1402-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Mar 8, 2023Completed
There is a potential for breakage of the small screw used to affix the anti-backout plate.
Z-1401-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Mar 8, 2023Completed
There is a potential for breakage of the small screw used to affix the anti-backout plate.
Z-1400-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported MectaLIF Anterior problems
Device problems
- Fracture4
Patient problems
- No Clinical Signs, Symptoms or Conditions4
MectaLIF Anterior models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MectaLIF Anterior 03.30.301Intervertebral Fusion Device With Integrated Fixation, Lumbar1 recall2 reports
- MectaLIF Anterior 03.30.300Intervertebral Fusion Device With Integrated Fixation, Lumbar1 recall1 report
- MectaLIF Anterior 03.30.302Intervertebral Fusion Device With Integrated Fixation, Lumbar1 recall1 report
- MectaLIF Anterior 03.30.303Intervertebral Fusion Device With Integrated Fixation, Lumbar1 recall0 reports
- MectaLIF Anterior 03.30.304Intervertebral Fusion Device With Integrated Fixation, Lumbar1 recall0 reports
- MectaLIF Anterior 03.30.305Intervertebral Fusion Device With Integrated Fixation, Lumbar1 recall0 reports
Recent MectaLIF Anterior adverse event reports
The 4 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionOct 30, 2025Fracture; Fracture
DURING PRIMARY SPINAL SURGERY AT L4-5, THE FIXED ANGLE AWL BROKE OFF IN THE BONE, THE SURGEON PULLED IT OUT AND USED A DIFFERENT FIXED ANGLE AWL TO MAKE THE HOLE FOR THE SCREW. SURGICAL STEPS PERFORMED: DISCECTOMY, TRIAL, MECTALIF IMPLANT, AWL FOR SCREW HOLES, SCREWS INSERTION AND THE COVER PLATE PLACEMENT. NO TAPPING/DRILLING PERFORMED. DURING CAUDAL SCREW INSERTION, THE SCREWDRIVER BROKE, AND A BACKUP SCREWDRIVER WAS REQUIRED. ADDITIONALLY, WHILE ATTACHING THE ANTI-BACKOUT LAG PLATE, THE ANTI-BACKOUT SCREW ON THE COVER PLATE BROKE OFF WHEN BEING TIGHTENED BY THE TORQUE LIMITER. IT WAS NOTED THAT THE BONE WAS SCLEROTIC, AND THE SURGEON DETERMINED THERE WAS NO RISK OF SCREW BACKOUT. THE BROKEN PORTION OF THE SCREW REMAINED IN THE ANTERIOR PLATE, PREVENTING THE PLACEMENT OF ANOTHER COVER PLATE. THE SURGERY WAS COMPLETED WITHOUT THE COVER PLATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23424083 ↗MalfunctionSep 9, 2024Fracture; Fracture
THE ANTI-BACKOUT SCREW CHIPPED OFF IN THE IMPLANT AND THE SURGEON WAS NOT ABLE TO INSERT IT. HE LEFT THE BROKEN THREADED PORTION OF THE SCREW IN THE IMPLANT AND THEN USED A NON-MEDACTA ANTERIOR PLATE AS A MEANS TO PREVENT SCREW BACK OUT. THE SURGEON CONFIRMED THAT THE SCREW SHEARED OFF AS HE WAS ATTEMPTING TO TIGHTEN IT USING THE STANDARD TORQUE DRIVER. HE DID NOT USE A MALLET OR ANY OTHER INSTRUMENT. THERE WAS A 5-MINUTE DELAY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20167667 ↗MalfunctionMar 9, 2023Fracture; Fracture
DURING THE PRIMARY SPINE SURGERY, WHILE THE SURGEON WAS TIGHTENING THE ANTI BACK OUT LAG COVER PLATE, THE SURGEON THOUGHT HE HAD LOCKED THE PLATE. THE SURGEON THEN REMOVED THE PLATE HOLDER ALONG WITH THE DRIVER AND THE SURGEON THEN NOTICED THAT THE ANTIBACKOUT COVER PLATE WAS STILL ATTACHED TO THE PLATE HOLDER. THE SURGEON ALSO OBSERVED THAT THE TOP OF THE SCREW HAD BROKEN OFF FROM THE THREADED PORTION. THE SURGEON LEFT THE THREADED PORTION OF THE SCREW IN THE PLATE AND CONTINUED WITH THE CASE. NO POSTERIOR FIXATION PERFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16511523 ↗MalfunctionMar 9, 2023Fracture; Fracture
DURING THE PRIMARY SPINE SURGERY, WHEN THE SURGEON WAS ADDING THE ALIF ANTI-BACKOUT LAG PLATE, THE TORQUE LIMITER HANDLE DID NOT GIVE OFF A "CLICK" SOUND TO INDICATE WHEN TO STOP TORSIONAL PRESSURE/FORCE. AS A RESULT, THE SURGEON KEPT TRYING TO SCREW IN THE FACEPLATE AND THE ANTIBACKOUT SCREW BROKE IN HALF. THE DISTAL TIP OF THE ANTIBACKOUT SCREW COLD-FUSED INTO THE FACEPLATE. THE SURGEON LEFT THE 4 PRIMARY SCREWS AS THEY WERE AND COMPLETED THE CASE WITHOUT THE ANTIBACKOUT PLATE. THE SURGEON PERFORMED A POSTERIOR FIXATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16511522 ↗
Other Medacta International SA products
- GMK Sphere Total Knee System209 models · 2,306 reports
- GMK Primary Total Knee System99 models · 876 reports
- Shoulder System63 models · 716 reports
- AMIStem H Femoral Stems20 models · 679 reports
- Mpact Acetabular System68 models · 609 reports
- Mectacer Biolox Delta Femoral Ball Head15 models · 551 reports
- Quadra H femoral stems32 models · 354 reports
- GMK Revision Total Knee System71 models · 304 reports
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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