NA 47-4835-018-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024100985), received between Feb 12, 2026 and Feb 12, 2026 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

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

  IT WAS REPORTED THAT A CLINICAL STUDY PATIENT EXPERIENCED COMPLEX REGIONAL PAIN SYNDROME APPROXIMATELY TWO MONTHS POST-IMPLANTATION. THE SYMPTOMS SUBSEQUENTLY RESOLVED AND THE DEVICE REMAINED IMPLANTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Complex regional pain syndrome

  MAUDE report 24326985 ↗

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