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PASS LP B02316535ZRecalls & reported problems

Medicrea International · SHORT POST DUAL LEAD PEDICLE SCREW Ø6.5 mm x 35 mm + BREAK AWAY NUT (X2) · Class 2

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.

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. How this data works · Data updated Oct 13, 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-2458-2023 · Root cause: Under Investigation by firm · FDA record ↗

Other Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease devices

All Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.