CalibrateRecalls & reported problems across all models
Alphatec Spine, Inc. · 44 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names at least one Calibrate model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 40
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls
- 1
We found 44 models of Calibrate by Alphatec Spine, Inc. in the FDA's device registry (GUDID). Together they are named in 40 adverse event reports in the FDA's MAUDE database, received between Apr 9, 2022 and Sep 23, 2026 — classified as 10 injuries, 30 malfunctions.
The most frequently reported specific device problem is “Collapse” (34 reports).
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
Reports received per month, all models
Calibrate 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.
- Dec 15, 2024Class IIOpen, Classified
Complaints have been received regarding post-operative implant collapse.
Z-1065-2025 · Root cause: Under Investigation by firm · names 27 of these models · Recall details · FDA record ↗
Most reported Calibrate problems
Device problems
- Collapse34
- Migration4
- Fracture2
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Mechanical Problem1
Patient problems
- Failure of Implant20
- No Clinical Signs, Symptoms or Conditions20
- Pain6
- Insufficient Information5
- Back pain1
- Unspecified Musculoskeletal problem1
Calibrate models
44 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Calibrate 325-07103005Intervertebral fusion device with bone graft, lumbar1 recall3 reports
- Calibrate 325-07103015Intervertebral fusion device with bone graft, lumbar1 recall3 reports
- Calibrate 325-09103010Intervertebral fusion device with bone graft, lumbar1 recall2 reports
- Calibrate 326-07102615Intervertebral fusion device with bone graft, lumbar1 recall1 report
- Calibrate 325-07103010Intervertebral fusion device with bone graft, lumbar1 recall1 report
- Calibrate 325-07103510Intervertebral fusion device with bone graft, lumbar1 recall1 report
- Calibrate 326-07102205Intervertebral fusion device with bone graft, lumbar1 recall0 reports
- Calibrate 326-07102210Intervertebral fusion device with bone graft, lumbar1 recall0 reports
- Calibrate 326-07102215Intervertebral fusion device with bone graft, lumbar1 recall0 reports
- Calibrate 326-07102605Intervertebral fusion device with bone graft, lumbar1 recall0 reports
- Calibrate 326-07102610Intervertebral fusion device with bone graft, lumbar1 recall0 reports
- Calibrate 326-07103010Intervertebral fusion device with bone graft, lumbar1 recall0 reports
- Calibrate 326-09102205Intervertebral fusion device with bone graft, lumbar1 recall0 reports
- Calibrate 326-09102210Intervertebral fusion device with bone graft, lumbar1 recall0 reports
- Calibrate 326-09102605Intervertebral fusion device with bone graft, lumbar1 recall0 reports
- Calibrate 326-09102610Intervertebral fusion device with bone graft, lumbar1 recall0 reports
- Calibrate 326-11102610Intervertebral fusion device with bone graft, lumbar1 recall0 reports
- Calibrate 325-11103010Intervertebral fusion device with bone graft, lumbar1 recall0 reports
- Calibrate 325-07102510Intervertebral fusion device with bone graft, lumbar1 recall0 reports
- Calibrate 325-07102515Intervertebral fusion device with bone graft, lumbar1 recall0 reports
- Calibrate 325-07103515Intervertebral fusion device with bone graft, lumbar1 recall0 reports
- Calibrate 325-07102505Intervertebral fusion device with bone graft, lumbar1 recall0 reports
- Calibrate 325-09102505Intervertebral fusion device with bone graft, lumbar1 recall0 reports
- Calibrate 325-09102510Intervertebral fusion device with bone graft, lumbar1 recall0 reports
- Calibrate 325-09103005Intervertebral fusion device with bone graft, lumbar1 recall0 reports
- Calibrate CLCCXOIMPATRAY, SURGICAL, INSTRUMENT1 recall0 reports
- Calibrate CLCCXSIMPATRAY, SURGICAL, INSTRUMENT1 recall0 reports
- Calibrate 320-08103000Intervertebral fusion device with bone graft, lumbar3 reports
- Calibrate 325-PRO-07103010-SIntervertebral fusion device with bone graft, lumbar3 reports
- Calibrate 325-PRO-07103510-SIntervertebral fusion device with bone graft, lumbar3 reports
- Calibrate 320-08102500Intervertebral fusion device with bone graft, lumbar2 reports
- Calibrate 420-PRO-07102500-SIntervertebral fusion device with bone graft, lumbar2 reports
- Calibrate 420-PRO-07103000-SIntervertebral fusion device with bone graft, lumbar2 reports
- Calibrate 420-PRO-08102500-SIntervertebral fusion device with bone graft, lumbar2 reports
- Calibrate 420-PRO-09103000-SIntervertebral fusion device with bone graft, lumbar2 reports
- Calibrate 325-PRO-07143010-SIntervertebral fusion device with bone graft, lumbar2 reports
- Calibrate 320-07102500Intervertebral fusion device with bone graft, lumbar1 report
- Calibrate 261-06185015Intervertebral fusion device with integrated fixation, lumbar1 report
- Calibrate 420-PRO-09142500-SIntervertebral fusion device with bone graft, lumbar1 report
- Calibrate 420-PRO-12103000-SIntervertebral fusion device with bone graft, lumbar1 report
- Calibrate 261-PRO-08225515-SIntervertebral fusion device with bone graft, lumbar1 report
- Calibrate 325-PRO-07102505-SIntervertebral fusion device with bone graft, lumbar1 report
- Calibrate 325-PRO-07103015-SIntervertebral fusion device with bone graft, lumbar1 report
- Calibrate 325-07103005Intervertebral fusion device with bone graft, lumbar1 report
Recent Calibrate adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Collapse
It was reported that an expandable interbody cage had collapsed about 7 months postoperatively. The patient is asymptomatic, and there are no plans of revision surgery.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50871244 ↗MalfunctionJun 29, 2026Collapse
POSTOPERATIVE RADIOGRAPHIC IMAGING AT THE 3-MONTH FOLLOW-UP VISIT REVEALED THE EXPANDABLE CAGE HAD COLLAPSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25659154 ↗MalfunctionJun 29, 2026Collapse
AROUND 11 MONTHS POSTOPERATIVELY, RADIOGRAPHIC IMAGINING REVEALED A COLLAPSED EXPANDABLE CAGE.THE PATIENT IS ASYMPTOMATIC, AND THERE ARE NO PLANS FOR REVISION SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25659130 ↗MalfunctionMay 22, 2026Collapse
A PATIENT UNDERWENT A LUMBAR INTERVERTEBRAL FUSION PROCEDURE ON (B)(6) 2025. AN EXPANDABLE INTERBODY SPACER WAS IMPLANTED AND EXPANDED AS INTENDED. NO INTRAOPERATIVE COMPLICATIONS WERE REPORTED. AT THE 3-MONTH POSTOPERATIVE VISIT, RADIOGRAPHIC IMAGING REVEALED A COLLAPSE OF THE SPACER AT L5/S1.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 25256459 ↗MalfunctionMay 1, 2026Collapse
AN EXPANDABLE INTERBODY CAGE WAS IMPLANTED AS INTENDED DURING A SPINAL PROCEDURE ON (B)(6) 2026. NO INTRAOPERATIVE COMPLICATIONS WERE REPORTED. ABOUT 6 WEEKS POSTOPERATIVELY, RADIOGRAPHIC IMAGES REVEALED A COLLAPSED CAGE. THE PATIENT IS ASYMPTOMATIC, AND THERE ARE NO PLANS FOR REVISION SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25059140 ↗MalfunctionApr 20, 2026Collapse
AN EXPANDABLE INTERBODY CAGE WAS IMPLANTED AS INTENDED DURING A SPINAL PROCEDURE ON AN UNKNOWN DATE. NO INTRAOPERATIVE COMPLICATIONS WERE REPORTED. ABOUT 2 MONTHS POSTOPERATIVELY, RADIOGRAPHIC IMAGES REVEALED A COLLAPSE OF THE CAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24927125 ↗MalfunctionApr 20, 2026Collapse
AN EXPANDABLE INTERBODY CAGE WAS IMPLANTED AS INTENDED DURING A SPINAL PROCEDURE ON (B)(6) 2025. NO INTRAOPERATIVE COMPLICATIONS WERE REPORTED. BETWEEN 3 WEEKS AND 6 MONTHS POSTOPERATIVELY, RADIOGRAPHIC IMAGES REVEALED A COLLAPSE OF THE CAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24927073 ↗InjuryApr 13, 2026Migration
IT WAS REPORTED THAT A PATIENT FELL 5 DAYS POSTOPERATIVELY, CAUSING THE EXPANDABLE INTERBODY SPACER TO MIGRATE. REVISION SURGERY OCCURRED ON (B)(6) 2026 TO REMOVE AND REPLACE THE SPACER.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 24864188 ↗MalfunctionMar 31, 2026Collapse
AN EXPANDABLE INTERBODY CAGE WAS IMPLANTED AS INTENDED DURING A SPINAL PROCEDURE ON (B)(6)2025. NO INTRAOPERATIVE COMPLICATIONS WERE REPORTED. ABOUT 4 MONTHS POSTOPERATIVELY, RADIOGRAPHIC IMAGES REVEALED A COLLAPSE OF THE CAGE.
Patient problems: Insufficient Information
MAUDE report 24743299 ↗MalfunctionMar 5, 2026Collapse
AN EXPANDABLE INTERBODY CAGE WAS IMPLANTED AS INTENDED DURING A SPINAL PROCEDURE ON (B)(6) 2025. NO INTRAOPERATIVE COMPLICATIONS WERE REPORTED. AT THE 3-MONTH POSTOPERATIVE VISIT RADIOGRAPHIC IMAGES REVEALED A COLLAPSE OF THE CAGE. THE PATIENT IS ASYMPTOMATIC, AND THERE ARE NO PLANS FOR REVISION SURGERY.
Patient problems: Failure of Implant
MAUDE report 24523210 ↗MalfunctionFeb 6, 2026Collapse
AN EXPANDABLE INTERBODY CAGE WAS IMPLANTED AS INTENDED DURING A SPINAL PROCEDURE ON (B)(6) 2025. NO INTRAOPERATIVE COMPLICATIONS WERE REPORTED. AT THE 3-MONTH POSTOPERATIVE VISIT A RADIOGRAPHIC IMAGE IDENTIFIED A COLLAPSE OF THE CAGE. THE PATIENT IS ASYMPTOMATIC, AND THERE ARE NO PLANS FOR REVISION SURGERY.
Patient problems: Failure of Implant
MAUDE report 24283121 ↗MalfunctionFeb 2, 2026Collapse
AN EXPANDABLE INTERBODY CAGE WAS IMPLANTED AS INTENDED DURING AN ADJACENT SINGLE LEVEL L5/S1 TLIF PROCEDURE ON (B)(6) 2025. NO INTRAOPERATIVE COMPLICATIONS WERE REPORTED. AT THE 6-WEEK POSTOPERATIVE VISIT A RADIOGRAPHIC IMAGE IDENTIFIED A COLLAPSE OF THE CAGE. THE PATIENT IS ASYMPTOMATIC, AND NO REVISION SURGERY IS PLANNED.
Patient problems: Failure of Implant
MAUDE report 24241881 ↗MalfunctionDec 30, 2025Collapse; Collapse
AN EXPANDABLE INTERBODY CAGE WAS IMPLANTED AS INTENDED DURING A SPINAL PROCEDURE PERFORMED ON (B)(6) 2025. NO INTRAOPERATIVE COMPLICATIONS WERE REPORTED. AROUND 3 MONTHS POSTOPERATIVELY, RADIOGRAPHIC IMAGES IDENTIFIED A COLLAPSE OF THE CAGE.
Patient problems: Failure of Implant
MAUDE report 23924386 ↗InjuryDec 10, 2025Collapse; Collapse
AN EXPANDABLE INTERBODY CAGE WAS IMPLANTED AND EXPANDED AS INTENDED DURING A SPINAL PROCEDURE PERFORMED ON (B)(6) 2025. NO INTRAOPERATIVE COMPLICATIONS WERE REPORTED. ABOUT 3 MONTHS POSTOPERATIVELY, RADIOGRAPHIC IMAGING REVEALED THAT THE CAGE HAD COLLAPSED. THE PATIENT IS EXPERIENCING LOWER BACK PAIN. THE PATIENT IS BEING MONITORED, AND THERE IS NO REVISION SURGERY PLANNED.
Patient problems: Back pain; Failure of Implant
MAUDE report 23771981 ↗MalfunctionDec 4, 2025Fracture; Fracture
AN EXPANDABLE INTERBODY CAGE WAS IMPLANTED AND EXPANDED AS INTENDED DURING A SPINAL PROCEDURE PERFORMED ON AN UNKNOWN DATE. NO INTRAOPERATIVE COMPLICATIONS WERE REPORTED. ABOUT 2 MONTHS POSTOPERATIVELY, RADIOGRAPHIC IMAGING REVEALED THAT THE CAGE HAD FRACTURED. THE PATIENT IS ASYMPTOMATIC, AND THERE ARE NO PLANS FOR REVISION SURGERY.
Patient problems: Failure of Implant
MAUDE report 23717007 ↗
Other Alphatec Spine, Inc. products
- Invictus96 models · 448 reports
- IdentiTi31 models · 68 reports · 1 recall
- ATEC Lateral Navigation Disc Prep Instruments2 models · 0 reports · 2 recalls
- Arsenal18 models · 86 reports
- Illico20 models · 69 reports
- AMP5 models · 4 reports · 1 recall
- Insignia34 models · 54 reports
- Trestle Luxe24 models · 38 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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