IMPIX TLIFRecalls & reported problems across all models
Medicrea International · 5 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 TLIF model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 5 models of IMPIX TLIF by Medicrea International in the FDA's device registry (GUDID). None of them is named in an adverse event report in our data.
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
IMPIX TLIF 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-2457-2023 · Root cause: Under Investigation by firm · names 5 of these models · Recall details · FDA record ↗
IMPIX TLIF models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- IMPIX TLIF B15130611SIntervertebral Fusion Device With Bone Graft, Lumbar1 recall0 reports
- IMPIX TLIF B15130613SIntervertebral Fusion Device With Bone Graft, Lumbar1 recall0 reports
- IMPIX TLIF B15130615SIntervertebral Fusion Device With Bone Graft, Lumbar1 recall0 reports
- IMPIX TLIF B15130609SIntervertebral Fusion Device With Bone Graft, Lumbar1 recall0 reports
- IMPIX TLIF B15130607SIntervertebral Fusion Device With Bone Graft, Lumbar1 recall0 reports
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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