Stratum STRM-NL-3550STRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00817701022558), received between Oct 17, 2019 and Oct 17, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (1 report).

1 FDA recall record name this device's identifier.

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 9, 2019Terminated

   Product labeled as STRM-NL-3550ST, NL LP Screw 3.5x50mm ST, lot M1151 may contain the incorrect screw type and length

   Z-0534-2020 · Root cause: Labeling mix-ups · 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.

• MalfunctionOct 17, 2019Labelling, Instructions for Use or Training Problem; Device Markings/Labelling Problem; Inaccurate Information; Labelling, Instructions for Use or Training Problem; Device Markings/Labelling Problem; Inaccurate Information

  WHILE BUILDING A STRATUM FOOT PLATING SYSTEM SET, A SALES REPRESENTATIVE SELECTED A SCREW LABELED AS STRM-NL-3550ST AND NOTICED THE PRODUCT IN THE PACKAGE DID NOT MATCH THE INFORMATION ON THE LABEL. THE SCREW IN THE PACKAGE WAS VISIBLY A SHORTER LENGTH AND A DIFFERENT TYPE OF SCREW.

  Patient problems: Not Applicable

  MAUDE report 9205308 ↗