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T2 1806-1406SRecalls & reported problems

Stryker GmbH · Nail Insertion Sleeve, elastic SPI Diam.8-11 · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540715357), received between Feb 18, 2021 and Feb 18, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Inaccurate Information” (1 report).

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. May 27, 2021Open, Classified

    The devices have a different inner diameter than the diameter specified on the outer box label.

    Z-2171-2021 · Root cause: Process control · FDA record ↗

Most reported problems

Device problems

  • Inaccurate Information1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionFeb 18, 2021Inaccurate Information; Inaccurate Information

    IT WAS REPORTED THAT DURING SURGERY THE PHYSICIAN FOUND A DIFFERENT DEVICE FROM PACKAGING LABEL AT OPENING OF THE PACKAGING. THERE WAS 18061407S, Ø8MM-13MM IN THE 18061406S, Ø8MM-11MM PACKAGING.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11345796 ↗

Other ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES devices

All ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES devices →

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