Cancellous Screw, Locking 37592-65Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 09120034306181), received between May 18, 2017 and May 18, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Missing Value Reason” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K063166); 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 16, 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.

• MalfunctionMay 18, 2017Missing Value Reason; Missing Value Reason

  WE RECEIVED THE FEEDBACK FROM OUR DISTRIBUTOR, THAT THE DATA ON THE LABEL DIFFERS FROM THE CONTENT OF THE NON-STERILE IMPLANT PACKAGING. THE INFORMATION ON THE LABEL SHOWED A CANCELLOUS LOCKING SCREW 5.9MM AND THE CONTENT WAS A STABILIZATION LOCKING SCREW 2.4MM. THE ISSUE WAS IDENTIFIED AT GOODS-IN INSPECTION FROM OUR DISTRIBUTOR, SO THERE WAS NO RISK ASSOCIATED WITH A PATIENT, SURGEON OR THIRD PARTY. THE SCREWS GET DELIVERED NON-STERILE TO THE FACILITY, SO THE NON-CONFORMANCE GETS IDENTIFIED LATEST AT REFILLING THE STERILIZATION TRAY PRIOR TO THE CLEANING AND DISINFECTION PROCESS AND PRIOR TO ANY SURGERY.

  Patient problems: Missing Value Reason

  MAUDE report 6575103 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K063166. One submission often covers many models, so check the product and lot details in each record.

• Z-1600-2026 · Jan 23, 2026 · Open, Classified
  Pelvic Reconstruction System (PRS) with the below descriptions and corresponding article numbers. 1. Fixation Screw; Article Number: 70312. 2. Spike short; Article Number: 7031
• Z-1718-2019 · May 9, 2019 · Open, Classified
  Rim Plate, 10-Hole, Left, PRS RX System. Titanium, implantable - Product Usage: The implant temporarily stabilizes bone segments until bony consolidation has taken place. After th