VitalityRecalls & reported problems across all models

We found 38 models of Vitality by Biomet Spine LLC in the FDA's device registry (GUDID). Together they are named in 157 adverse event reports in the FDA's MAUDE database, received between Aug 27, 2019 and Jun 12, 2026 — classified as 79 injuries, 78 malfunctions.

The most frequently reported specific device problem is “Migration” (41 reports).

4 FDA recall records 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

Vitality 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. Oct 16, 2023Class IIOpen, Classified

   Spinal fixation system 7.5mmx 50mm screws are packaged with the correct labeling, but the screws themselves were laser marked with an incorrect size description of 7.5 x 40; use of incorrect screws could lead to screw perforation and indention of vascular or other structures.

   Z-0639-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

2. Jul 30, 2018Class IITerminated

   The Vitality Shear-off Set Screw is not threading properly with the mating tulip head of the Vitality screws, hooks and connectors due to a manufacturing issue.These devices are indicated as an adjunct to fusion for various indications

   Z-0868-2019 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

3. Jul 30, 2018Class IITerminated

   The Vitality Shear-off Set Screw is not threading properly with the mating tulip head of the Vitality screws, hooks and connectors due to a manufacturing issue.These devices are indicated as an adjunct to fusion for various indications

   Z-0867-2019 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

4. Jul 30, 2018Class IITerminated

   The Vitality Shear-off Set Screw is not threading properly with the mating tulip head of the Vitality screws, hooks and connectors due to a manufacturing issue.These devices are indicated as an adjunct to fusion for various indications

   Z-0866-2019 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported Vitality problems

Vitality models

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

• Vitality® 07.02011.001

  Orthosis, spinal pedicle fixation, for degenerative disc disease
  3 recalls0 reports
• Vitality® 07.02000.118

  Orthosis, spinal pedicle fixation, for degenerative disc disease
  1 recall17 reports
• Vitality® 07.02010.001

  Orthosis, spinal pedicle fixation, for degenerative disc disease
  57 reports
• Vitality® 730M0017

  Thoracolumbosacral Pedicle Screw System
  14 reports
• VITALITY® 701M6540

  Thoracolumbosacral pedicle screw system
  7 reports
• VITALITY® 701M6545

  APPLIANCE, FIXATION, SPINAL INTERLAMINAL
  7 reports
• VITALITY® 709M8555

  Appliance, fixation, spinal intervertebral body
  5 reports
• VITALITY® 701M7550

  Thoracolumbosacral pedicle screw system
  4 reports
• VITALITY® 709M8550

  APPLIANCE, FIXATION, SPINAL INTERLAMINAL
  4 reports
• Vitality® 07.02027.001

  Appliance, fixation, spinal intervertebral body
  4 reports
• VITALITY® 701M6535

  Appliance, fixation, spinal intervertebral body
  2 reports
• Vitality® 730M0024

  Thoracolumbosacral pedicle screw system
  2 reports
• Vitality® 07.02000.116

  Orthosis, spinal pedicle fixation, for degenerative disc disease
  2 reports
• Vitality® 07.02012.166

  APPLIANCE, FIXATION, SPINAL INTERLAMINAL
  2 reports
• Vitality® 07.02013.002

  Orthosis, spinal pedicle fixation, for degenerative disc disease
  2 reports
• Vitality® 07.02015.008

  Orthosis, spinal pedicle fixation, for degenerative disc disease
  2 reports
• Vitality® 07.02015.011

  Orthosis, spinal pedicle fixation, for degenerative disc disease
  2 reports
• Vitality® 07.02030.001

  Orthosis, spinal pedicle fixation, for degenerative disc disease
  2 reports
• Vitality® 07.02030.003

  Orthosis, spinal pedicle fixation, for degenerative disc disease
  2 reports
• Vitality® 07.02050.166

  Orthosis, spinal pedicle fixation, for degenerative disc disease
  2 reports
• VITALITY® 701M5535

  Thoracolumbosacral pedicle screw system
  1 report
• VITALITY® 701M5545

  APPLIANCE, FIXATION, SPINAL INTERLAMINAL
  1 report
• VITALITY® 701M7545

  Appliance, fixation, spinal intervertebral body
  1 report
• Vitality® 730M0021

  Thoracolumbosacral pedicle screw system
  1 report
• VITALITY® 730M1001

  PROBE
  1 report
• Vitality® 730M1002

  CURETTE
  1 report
• VITALITY® 730M1004

  PROBE
  1 report
• Vitality® 730M3045

  Thoracolumbosacral pedicle screw system
  1 report
• VITALITY® 704M8590

  Thoracolumbosacral pedicle screw system
  1 report
• VITALITY® 704M9500

  Appliance, fixation, spinal intervertebral body
  1 report
• VITALITY® 704M1570

  APPLIANCE, FIXATION, SPINAL INTERLAMINAL
  1 report
• Vitality® 708M5545

  Appliance, fixation, spinal intervertebral body
  1 report
• Vitality® 07.02000.075

  Orthosis, spinal pedicle fixation, for degenerative disc disease
  1 report
• Vitality® 07.02004.160

  Orthosis, spinal pedicle fixation, for degenerative disc disease
  1 report
• Vitality® 07.02030.002

  Orthosis, spinal pedicle fixation, for degenerative disc disease
  1 report
• Vitality® 07.02030.004

  APPLIANCE, FIXATION, SPINAL INTERLAMINAL
  1 report
• Vitality® 07.02033.001

  Orthosis, spinal pedicle fixation, for degenerative disc disease
  1 report
• Vitality® 07.02048.002

  Orthosis, spinal pedicle fixation, for degenerative disc disease
  1 report

Recent Vitality adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2026Fracture

  IT WAS REPORTED THAT THE DISTAL 10 MM TIP OF A CURVED PROBE FRACTURED INSIDE THE PEDICLE DURING SURGERY. APPROXIMATELY 50 MINUTES WERE REQUIRED TO REMOVE THE BROKEN FRAGMENT. THE AREA SURROUNDING THE FRACTURED TIP WAS SHAVED USING A 2 MM AIR DRILL DIAMOND BURR, AND THE FRAGMENT WAS REMOVED USING FINE-TIPPED PLIERS. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25491051 ↗
• MalfunctionJan 20, 2026Fracture

  IT WAS REPORTED THAT A VITAL MIS TAP FRACTURED WHILE DRILLING INTO THE PATIENT. THE ITEM WAS REMOVED FROM THE PATIENT AND THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24118848 ↗
• MalfunctionNov 14, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A SURGERY, A VITAL REDUCER TOWER SPLAYED UNDER STRESS. THERE WAS NO PATIENT HARM OR PROCEDURAL DELAY. UPON MANUFACTURER INVESTIGATION, IT WAS DISCOVERED THAT THE VITAL REDUCER TOWER WAS ALSO FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23556262 ↗
• InjuryOct 15, 2025Migration; Migration

  IT WAS REPORTED THAT A VITAL MIS SCREW HEAD BROKE OFF DURING IMPLANT REMOVAL SURGERY. IMPLANT REMOVAL WAS PERFORMED BECAUSE THE CLOSURE TOP HAD COME OFF AND FUSION WAS COMPLETED. THERE WAS NO PATIENT HARM OR PROCEDURAL DELAY. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23304351 ↗
• MalfunctionAug 29, 2025Material Fragmentation; Material Deformation; Material Fragmentation; Material Deformation

  IT WAS REPORTED THAT HE CENTRAL SCREW SECTION OF THE ADJ CROSSLINK WAS DAMAGED. DURING THE FINAL TIGHTENING PROCESS, THE THREADS WERE STRIPPED, PREVENTING PROPER FASTENING, AND METAL FRAGMENTS WERE ALSO OBSERVED. THERE WAS NO PATIENT HARM OR PROCEDURAL IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22923246 ↗
• MalfunctionJul 23, 2025Wrong Label; Wrong Label

  A DISTRIBUTOR REPORTED THAT THEY RECEIVED A SEALED PACKAGE FOR A 6.5X45MM SCREW WHICH INSTEAD CONTAINED A CONNECTOR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22577293 ↗
• MalfunctionJun 12, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT AFTER REMOVING A VITALITY ADJUSTABLE TRANSVERSE CONNECTOR TO REPOSITION IT, THE SCREW ON ONE SIDE BECAME STUCK AND IT COULD NOT BE RE-INSTALLED. THE SAME SIZED VITALITY ADJUSTABLE TRANSVERSE CONNECTOR WAS USED TO COMPLETE THE PROCEDURE; THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22197059 ↗
• MalfunctionJun 3, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING INSPECTION OF A FIELD RETURN FROM A HOSPITAL, A WAREHOUSE DISCOVERED A FRACTURED TIP ON A VITAL T27 FINAL DRIVER. THE HOSPITAL DID NOT PROVIDE ANY PATIENT OR EVENT INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 22136065 ↗
• MalfunctionMay 27, 2025Migration; Migration

  IT WAS REPORTED THAT TWO VITAL MIS SET SCREWS MIGRATED OUT OF THEIR BONE SCREWS POST-OPERATIVELY. THIS WAS DISCOVERED VIA X-RAY DURING A FOLLOW-UP APPOINTMENT APPROXIMATELY SIX WEEKS AFTER THE INITIAL SURGERY. THE PATIENT HAS NOT BEEN SCHEDULED FOR A REVISION AND THE SURGEON WILL MONITOR THE PATIENT. THIS IS REPORT TWO OF FOUR FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22088921 ↗
• MalfunctionMay 27, 2025Migration; Migration

  IT WAS REPORTED THAT TWO VITAL MIS SET SCREWS MIGRATED OUT OF THEIR BONE SCREWS POST-OPERATIVELY. THIS WAS DISCOVERED VIA X-RAY DURING A FOLLOW-UP APPOINTMENT APPROXIMATELY SIX WEEKS AFTER THE INITIAL SURGERY. THE PATIENT HAS NOT BEEN SCHEDULED FOR A REVISION AND THE SURGEON WILL MONITOR THE PATIENT. THIS IS REPORT ONE OF FOUR FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22088888 ↗
• InjuryMay 21, 2025Migration; Migration

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO REMOVE AND REPLACE A CLOSURE TOP THAT HAD MIGRATED OUT OF ITS MATING PEDICLE SCREW POST-OPERATIVELY. THE SURGEON DECIDED TO OBSERVE THE PATIENT FOR A FEW MONTHS BEFORE PERFORMING THE REVISION. THE ORIGINAL SCREW WAS KEPT IN PLACE AND ONLY THE CLOSURE TOP WAS EXPLANTED WITH NO PATIENT IMPACT. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22063415 ↗
• MalfunctionMay 7, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT INTRA-OPERATIVELY, THE THREADS OF THREE VITALITY CLOSURE TOPS AND ONE VITAL MIS SCREW STRIPPED DURING INSERTION. A SECOND SCREW AND FOURTH PLUG WERE USED TO COMPLETE THE SURGERY, AND THERE WAS NO PATIENT IMPACT, HOWEVER THERE WAS A 20 MINUTE DELAY TO THE PROCEDURE. THIS IS REPORT THREE OF FOUR FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21978677 ↗
• MalfunctionMay 7, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT INTRA-OPERATIVELY, THE THREADS OF THREE VITALITY CLOSURE TOPS AND ONE VITAL MIS SCREW STRIPPED DURING INSERTION. A SECOND SCREW AND FOURTH PLUG WERE USED TO COMPLETE THE SURGERY, AND THERE WAS NO PATIENT IMPACT, HOWEVER THERE WAS A 20 MINUTE DELAY TO THE PROCEDURE. THIS IS REPORT FOUR OF FOUR FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21978676 ↗
• MalfunctionMay 7, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT INTRA-OPERATIVELY, THE THREADS OF THREE VITALITY CLOSURE TOPS AND ONE VITAL MIS SCREW STRIPPED DURING INSERTION. A SECOND SCREW AND FOURTH PLUG WERE USED TO COMPLETE THE SURGERY, AND THERE WAS NO PATIENT IMPACT, HOWEVER THERE WAS A 20 MINUTE DELAY TO THE PROCEDURE. THIS IS REPORT TWO OF FOUR FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21978659 ↗
• MalfunctionMay 7, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT INTRA-OPERATIVELY, THE THREADS OF THREE VITALITY CLOSURE TOPS AND ONE VITAL MIS SCREW STRIPPED DURING INSERTION. A SECOND SCREW AND FOURTH PLUG WERE USED TO COMPLETE THE SURGERY, AND THERE WAS NO PATIENT IMPACT, HOWEVER THERE WAS A 20 MINUTE DELAY TO THE PROCEDURE. THIS IS REPORT ONE OF FOUR FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21978652 ↗

Other Biomet Spine LLC products

• Vital30 models · 12 reports · 24 recalls
• POLARIS 5.5 SPINAL SYSTEM17 models · 74 reports
• Vital MIS Spinal Fixation System11 models · 25 reports