NA 47-4835-045-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024101340), received between Jul 30, 2025 and Jan 12, 2026 — classified as 2 injuries.

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

5 other recalls cover devices cleared under the same FDA submission (K060710); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A STUDY DATABASE THAT A PATIENT HAD A SYNDESMOTIC SCREW REMOVED ON THE DAY OF THE INITIAL PROCEDURE DUE TO SOFT-TISSUE INTERPOSITION PREVENTING REDUCTION WITH ONGOING DISTAL TIBIOFIBULAR DIASTASIS; THE PATIENT ALSO DEVELOPED A WOUND INFECTION WITH A DISCHARGING SINUS THAT REQUIRED MULTIPLE COURSES OF ORAL ANTIBIOTICS. ONLY THE SCREW WAS REMOVED. BOTH EVENTS WERE CONSIDERED POSSIBLY RELATED TO THE PROCEDURE AND THE DEVICE. BOTH EVENTS RESOLVED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Loss of fracture reduction; Post Operative Wound Infection

  MAUDE report 24032069 ↗
• InjuryJul 30, 2025Fracture; Fracture

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 22668436 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K060710. One submission often covers many models, so check the product and lot details in each record.

• Z-0312-2020 · Oct 10, 2019 · Terminated
  Universal Locking Plates Sterile, Item Nos. 47492800207 47492800303 47492800402 47492800403 47492800407 47492800502 47492800503 47492800507 47492800603 47492800607 4749
• Z-1673-2016 · May 4, 2016 · Terminated
  Zimmer Plates and Screws (ZPS) 3.5 mm Cortical Screw SelfTapping, 10 mm Length 47483501001 3.5 mm Cortical Screw SelfTapping, 14 mm Length 47483501401 3.5 mm Cortical Screw Self
• Z-1106-2016 · Jan 11, 2016 · Terminated
  Product 8 consists of all products under product code HWC, and same usage: Item no: 47483501201 3.5MM CORT. SCREW 12MM LN 47483501401 3.5MM CORT. SCREW 14MM LN 47483501601 3.5MM C
• Z-0654-2016 · Dec 9, 2015 · Terminated
  Zimmer Universal Locking System 3.5mm Locking Reconstruction Plate Straight 11 Holes 144mm Length Zimmer Universal Locking System 3.5mm Locking Dual Compression Plate 8 Holes 105mm
• Z-1042-2014 · Oct 11, 2013 · Terminated
  1.5 X 6 CORT SCREW HEX/SE 2.0 X 6 CORT SCREW HEX/SE 2.0 X 10 CORT SCREW CRUCI 2.0 X 12 CORT SCREW CRUCI 2.0 X 14 CORT SCREW CRUCI 2.0 X 16 CORT SCREW HEX/S 2.0 X 16 CORT SCREW CRUC