IMPIX 3D PrintRecalls & reported problems across all models
Medicrea International · 38 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names at least one IMPIX 3D Print model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 1
We found 38 models of IMPIX 3D Print by Medicrea International in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, received between Oct 4, 2024 and Oct 4, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Migration” (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
Reports received per month, all models
IMPIX 3D Print 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.
- Jul 12, 2023Class IIOpen, Classified
There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
Z-2452-2023 · Root cause: Under Investigation by firm · names 38 of these models · Recall details · FDA record ↗
Most reported IMPIX 3D Print problems
Device problems
- Migration1
Patient problems
- Inadequate Osseointegration1
- Numbness1
- Pain1
IMPIX 3D Print models
38 models, most reported first. Each model has its own page with its reports, recalls and device details.
- IMPIX 3D Print B242C12062810Intervertebral Fusion Device With Bone Graft, Lumbar1 recall1 report
- IMPIX 3D Print B242C10062810Intervertebral Fusion Device With Bone Graft, Lumbar1 recall0 reports
- IMPIX 3D Print B242C11062810Intervertebral Fusion Device With Bone Graft, Lumbar1 recall0 reports
- IMPIX 3D Print B242C13062810Intervertebral Fusion Device With Bone Graft, Lumbar1 recall0 reports
- IMPIX 3D Print B247C08062810Intervertebral Fusion Device With Bone Graft, Lumbar1 recall0 reports
- IMPIX 3D Print B247C08062410Intervertebral Fusion Device With Bone Graft, Lumbar1 recall0 reports
- IMPIX 3D Print B247C08063210Intervertebral Fusion Device With Bone Graft, Lumbar1 recall0 reports
- IMPIX 3D Print B247C09062410Intervertebral Fusion Device With Bone Graft, Lumbar1 recall0 reports
- IMPIX 3D Print B247C09062810Intervertebral Fusion Device With Bone Graft, Lumbar1 recall0 reports
- IMPIX 3D Print B247C09063210Intervertebral Fusion Device With Bone Graft, Lumbar1 recall0 reports
- IMPIX 3D Print B247C10062410Intervertebral Fusion Device With Bone Graft, Lumbar1 recall0 reports
- IMPIX 3D Print B247C10062810Intervertebral Fusion Device With Bone Graft, Lumbar1 recall0 reports
- IMPIX 3D Print B247C10063210Intervertebral Fusion Device With Bone Graft, Lumbar1 recall0 reports
- IMPIX 3D Print B247C11062410Intervertebral Fusion Device With Bone Graft, Lumbar1 recall0 reports
- IMPIX 3D Print B247C11062810Intervertebral Fusion Device With Bone Graft, Lumbar1 recall0 reports
- IMPIX 3D Print B247C11063210Intervertebral Fusion Device With Bone Graft, Lumbar1 recall0 reports
- IMPIX 3D Print B247C12062410Intervertebral Fusion Device With Bone Graft, Lumbar1 recall0 reports
- IMPIX 3D Print B247C12062810Intervertebral Fusion Device With Bone Graft, Lumbar1 recall0 reports
- IMPIX 3D Print B247C12063210Intervertebral Fusion Device With Bone Graft, Lumbar1 recall0 reports
- IMPIX 3D Print B247C13062410Intervertebral Fusion Device With Bone Graft, Lumbar1 recall0 reports
- IMPIX 3D Print B247C13062810Intervertebral Fusion Device With Bone Graft, Lumbar1 recall0 reports
- IMPIX 3D Print B247C13063210Intervertebral Fusion Device With Bone Graft, Lumbar1 recall0 reports
- IMPIX 3D Print B247C14062410Intervertebral Fusion Device With Bone Graft, Lumbar1 recall0 reports
- IMPIX 3D Print B247C14062810Intervertebral Fusion Device With Bone Graft, Lumbar1 recall0 reports
- IMPIX 3D Print B247C14063210Intervertebral Fusion Device With Bone Graft, Lumbar1 recall0 reports
- IMPIX 3D Print B247C15062810Intervertebral Fusion Device With Bone Graft, Lumbar1 recall0 reports
- IMPIX 3D Print B247C15063210Intervertebral Fusion Device With Bone Graft, Lumbar1 recall0 reports
- IMPIX 3D Print B247C07062410Intervertebral Fusion Device With Bone Graft, Lumbar1 recall0 reports
- IMPIX 3D Print B247C07062810Intervertebral Fusion Device With Bone Graft, Lumbar1 recall0 reports
- IMPIX 3D Print B247C07063210Intervertebral Fusion Device With Bone Graft, Lumbar1 recall0 reports
- IMPIX 3D Print B242C09122810Intervertebral Fusion Device With Bone Graft, Lumbar1 recall0 reports
- IMPIX 3D Print B242C10122810Intervertebral Fusion Device With Bone Graft, Lumbar1 recall0 reports
- IMPIX 3D Print B242C11122810Intervertebral Fusion Device With Bone Graft, Lumbar1 recall0 reports
- IMPIX 3D Print B242C12122810Intervertebral Fusion Device With Bone Graft, Lumbar1 recall0 reports
- IMPIX 3D Print B242C13122810Intervertebral Fusion Device With Bone Graft, Lumbar1 recall0 reports
- IMPIX 3D Print B242C14122810Intervertebral Fusion Device With Bone Graft, Lumbar1 recall0 reports
- IMPIX 3D Print B242C15122810Intervertebral Fusion Device With Bone Graft, Lumbar1 recall0 reports
- IMPIX 3D Print B242C12123310Intervertebral Fusion Device With Bone Graft, Lumbar1 recall0 reports
Recent IMPIX 3D Print adverse event reports
The 1 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryOct 4, 2024Migration; Migration
INFORMATION WAS RECEIVED FROM A PATIENT'S HUSBAND REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE PATIENT HAD LEG NUMBNESS AND BACK PAIN. THE CAGE HAS MOVED SINCE SURGERY AND SCREWS LOOSENING WERE REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE EVENT. PATIENT'S SPOUSE REPORTED THAT HIS WIFE IS HAVING LEG NUMBNESS ON LEFT SIDE AND LEG WEAKNESS AND EXPERIENCING NERVE PAIN FROM LOWER BACK TO HER HIP DOWN HER LEG TO HER TOES. SHE CAN¿T STAND FOR A LONG PERIOD OF TIME DUE TO WEAKNESS. THE PATIENT HAD HER FIRST SURGERY ON (B)(6) 2021 AND ALSO HAD A 2ND SURGERY ON (B)(6) 2024 WHICH WAS A REVISION SURGERY. THE REASON FOR REVISION SURGERY IS UNKNOWN. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: Inadequate Osseointegration; Numbness; Pain
MAUDE report 20366430 ↗
Other Medicrea International products
All Medicrea International devices →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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