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IMPIX 3D Print B247C08062810Recalls & reported problems

Medicrea International · IB3D TO (C) 08 x 06° x 28 x 10 · Class 2 · Implant

All models of IMPIX 3D Print (38)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K163595); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

  1. Jul 12, 2023Open, 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 · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K163595. One submission often covers many models, so check the product and lot details in each record.

  • Z-1156-2020 · Oct 2, 2019 · Terminated
    Medicrea TLIF-B Holder, short intended for Intervertebral body fusion device Catalog: Number A24200010

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Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page