NA 04.210.120TSRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982262622), received between Jun 27, 2025 and Jun 27, 2025 — classified as 1 injury.

9 other recalls cover devices cleared under the same FDA submission (K071184, K100776, K102694, K103243); 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.

• InjuryJun 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN UNKNOWN SURGERY FOR RADIUS WITH THE PLATE AND THE SCREWS. AS THE BONE ADHESION RESULTED, THE REMOVAL SURGERY WAS PERFORMED ON (B)(6) 2025. AT THAT TIME, IT WAS DISCOVERED THAT THE MOST DISTAL MOST ULNAR SCREW HAD BROKEN AT THE NECK. THE BROKEN SCREW SHAFT WAS SLIGHTLY PROTRUDING, SO IT WAS FILED DOWN WITH A HALO REAMER AND REMOVED WITH AN EXTRACTION BOLT. THE SURGEON CONFIRMED THAT THERE WAS NO RESIDUE BASED ON THE FLUOROSCOPY AND POSTOPERATIVE X-RAYS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30MINS OF DELAY. ON JUN 10, 2025, THE SALES REP LOOKED AT THE X-RAYS AND CT SCANS WITH THE SURGEON, BUT IT IS UNCLEAR WHEN THE SCREW BROKE. NO FURTHER INFORMATION IS AVAILABLE. NOTE: TWO SCREW PART NUMBERS ARE LISTED, BUT IT IS UNCLEAR WHICH ONE BROKE. LOOKING AT THE HISTORY AT THE TIME, ONLY THE ABOVE TWO-PART NUMBERS WERE USED.

  Patient problems: Adhesion(s)

  MAUDE report 22351190 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K071184, K100776, K102694, K103243. One submission often covers many models, so check the product and lot details in each record.

• Z-0883-2020 · Dec 16, 2019 · Terminated
  2.4MM TI VA LOCKING SCREW STARDRIVE 24MM STERILE, Part Number 04.210.124TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the ste
• Z-0880-2020 · Dec 16, 2019 · Terminated
  2.4MM TI VA LOCKING SCREW STARDRIVE 12MM STERILE, Part Number 04.210.112TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the ste
• Z-0882-2020 · Dec 16, 2019 · Terminated
  2.4MM TI VA LOCKING SCREW STARDRIVE 18MM STERILE, Part Number 04.210.118TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the ste
• Z-0881-2020 · Dec 16, 2019 · Terminated
  2.4MM TI VA LOCKING SCREW STARDRIVE 16MM STERILE, Part Number 04.210.116TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the ste
• Z-0879-2020 · Dec 16, 2019 · Terminated
  2.4MM TI VA LOCKING SCREW STARDRIVE 10MM STERILE, Part Number 04.210.110TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the ste
• Z-2389-2016 · Jun 28, 2016 · Terminated
  Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Plate, Fixation, Bone,
• Z-0323-2016 · Nov 2, 2015 · Terminated
  2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone frag
• Z-2057-2013 · May 31, 2013 · Terminated
  Synthes 2.4mm VA-LCP Two Column Volar Distal Radius Plate and Torque limiting attachment, 1.2Nm Synthes VA-LCP Distal Radius System is intended for fixation of complex intra- and
• Z-0956-2013 · Jan 11, 2013 · Terminated
  Variable Angle Locking Compression Plate/VA-LCP Dorsal Distal Radius Plate, Part Number 02.115.431. Indicated for: Dorsally displaced fractures, Open joint reconstruction, and Cor