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PRECICE® STRYDE System STP5-425Recalls & reported problems

Nuvasive Specialized Orthopedics, Inc. · 5.0mm x 42.5mm Locking Screws, Partially · Class 2

2 open recalls name 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
2

Summary

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

2 FDA recall records name this device's identifier, 2 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. Oct 29, 2021Open, Classified

    The Instructions for Use have been updated to include: (1) Clarification that the device is intended for use only in patients 18 years and older, (2) That patients should weigh 50 lbs. or more while undergoing treatment, and (3) That no more than two devices should be implanted at a time.

    Z-0319-2022 · Root cause: Device Design · FDA record ↗

  2. Feb 12, 2021Open, Classified

    Due to complaints of adverse events potentially related to biological safety. The complaints included report of pain and bony abnormalities at the interface between the telescoping nail segments.

    Z-1323-2021 · Root cause: Under Investigation by firm · FDA record ↗

Other Screw, Fixation, Bone devices

All Screw, Fixation, Bone devices →

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