PRECICE® STRYDE System PS11.5-80SJ280Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887517951687), received between Mar 16, 2021 and Apr 7, 2021 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Material Discolored” (3 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Oct 29, 2021Class IIOpen, 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 · Recall details · FDA record ↗

2. Feb 12, 2021Class IIOpen, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 7, 2021Material Discolored; Material Discolored

  NO NEW INFORMATION PROVIDED.

  Patient problems: Osteolysis

  MAUDE report 11631387 ↗
• MalfunctionMar 16, 2021Material Discolored; Material Discolored

  IT WAS REPORTED THAT UPON REMOVAL OF THE NAIL AFTER IT HAD ACHIEVED ITS INTENDED PURPOSE AND OUTCOME, THERE WAS RUST NOTED ON THE JUNCTION OF THE NAIL. NO PATIENT IMPACT OR ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11499272 ↗
• MalfunctionMar 16, 2021Material Discolored; Material Discolored

  IT WAS REPORTED THAT UPON REMOVAL OF THE NAIL AFTER IT HAD ACHIEVED ITS INTENDED PURPOSE AND OUTCOME, THERE WAS RUST NOTED ON THE JUNCTION OF THE NAIL. NO PATIENT IMPACT OR ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11499256 ↗