Torx Cortical Screw TRX2.3-16Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842188108624), received between Feb 9, 2018 and Feb 9, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Contamination with Body Fluid” (1 report).

1 other recall cover devices cleared under the same FDA submission (K951302); they may or may not involve this specific model.

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.

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.

• MalfunctionFeb 9, 2018Device Contamination with Body Fluid; Device Contamination with Body Fluid

  DURING SURGERY ON (B)(6) 2018, A TRX2.3-16 (LOT #92820) SCREW WAS FOUND TO HAVE BLOOD ON IT. A TECH DISCOVERED THE SCREW HAD BLOOD ON IT AND IMMEDIATELY REMOVED THE SCREW FROM THE STERILE FIELD. THE PATIENT WAS SAVED FROM ANY CROSS CONTAMINATION. THIS IS THE FIRST OCCURRENCE OF THIS KIND FOR THIS TYPE OF PRODUCT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7260127 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K951302. One submission often covers many models, so check the product and lot details in each record.

• Z-0118-2020 · Aug 24, 2018 · Terminated
  TriMed Dorsal Wrist Hook Plate, Dorsal, 4-Hole, REF WHD-4, contained in a tray, insert, or poly package containing varying amounts, Nonsterile, Single Use Only, Rx. The firm name