BONE SCREWS Self Tapping (REF 8420.15.005)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08033390110693), received between Nov 18, 2025 and Nov 18, 2025 — classified as 1 injury.

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

2 other recalls cover devices cleared under the same FDA submission (K172456); 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.

• InjuryNov 18, 2025Break; Degraded; Patient Device Interaction Problem; Break; Degraded; Patient Device Interaction Problem

  SHOULDER REVISION SURGERY WAS PERFORMED ON (B)(6) 2025. DURING REVISION PROCEDURE, THE LINER WAS REMOVED AND EXAMINED (SMR REVERSE LINER STANDARD, PART CODE 1360.50.810, LOT NUMBER 20AT0XN, STERILIZATION (B)(4)), NOT SHOWING SIGNIFICANT OR UNUSUAL SIGNS OF WEAR. THE REVERSE BODY WAS LEFT IN PLACE BECAUSE IT WAS DETERMINED THAT REMOVING WOULD THREATEN TO FRACTURE TUBEROSITIES. GLENOSPHERE (SMR ECCENT. GLENOSPHERE Ø 36MM, PART CODE 1376.09.031, LOT NUMBER 2009277, STERILIZATION (B)(4)) AND BONE SCREWS (BONE SCREW Ø6,5 H.15MM, PART CODE 8420.15.005, LOT NUMBER 1802866, STERILIZATION (B)(4); BONE SCREW Ø6,5 H.20MM, PART CODE 8420.15.010, LOT NUMBER 2006407, STERILIZATION (B)(4); BONE SCREW Ø6,5 H.40MM, PART CODE 8420.15.050, LOT NUMBER 2006421, STERILIZATION (B)(4)) WERE REMOVED. AT THIS POINT, THE BASEPLATE (TT AUGM.360 BASEPLATE #S-R+2MM, PART CODE 1375.15.522, LOT NUMBER 2008603, STERILIZATION (B)(4)) COULD BE PULLED OUT BY HAND WITH HEMOSTATS. DURING REMOVAL OF SCREWS, IT WAS NOTED THAT THERE WERE METAL SHAVINGS (APPARENTLY FROM THE SCREWS) LEFT BEHIND THE BASEPLATE. IT WAS HYPOTHESIZED THAT THIS DEBRIS MAY HAVE BEEN CREATED WHILE IMPLANTING THE SCREWS AT TOO AGGRESSIVE OF AN ANGLE

  Patient problems: Joint Laxity

  MAUDE report 23579327 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K172456. One submission often covers many models, so check the product and lot details in each record.

• Z-0159-2022 · Oct 1, 2021 · Terminated
  REF 8420.15.020, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=25mm, STERILE R, 2100099, UDI: (01)08033390018852
• Z-0160-2022 · Oct 1, 2021 · Terminated
  REF 8420.15.010, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=20mm, STERILE R, 2100099, UDI: (01)08033390018845