PRECICE® STRYDE System PS11.5-65SJ250Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887517951663), received between Mar 21, 2022 and Mar 21, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Discolored” (1 report).

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 ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 21, 2022Material Discolored; Material Discolored

  INFORMATION WAS RECEIVED THAT DURING EXPLANT THE NAIL WAS FOUND TO HAVE CORROSION ON THE TELESCOPIC PART. THE NAIL FUNCTIONED AS INTENDED AND NO PATIENT ADVERSE EVENT WAS REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 13839925 ↗