NA 47-4835-060-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024101425), received between Jul 30, 2025 and Jul 30, 2025 — classified as 1 injury.

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

• InjuryJul 30, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL IMPLANTATION OF A ZPS SYSTEM APPROXIMATELY ONE (1) YEAR AND SEVEN (7) MONTHS AGO AS PART OF A CLINICAL STUDY. SUBSEQUENTLY, THE PATIENT UNDERWENT REVISION/REMOVAL OF THE SCREW ON APPROXIMATELY SIX (6) MONTHS POST-IMPLANTATION DUE TO SCREW FRACTURE. DURING THE REVISION, THE DISTAL PORTION OF THE SCREW WAS LEFT IN THE TIBIA AS STANDARD PRACTICE AND THE PROXIMAL PART WAS REMOVED. THE PATIENT REPORTED ONGOING PAIN, SWELLING, AND DISCOMFORT IN THE ANKLE AND UNDERWENT ARTHROSCOPIC DEBRIDEMENT SIX (6) MONTHS AFTER THAT. THE EVENT IS REPORTED TO NOT BE RESOLVED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Foreign Body In Patient; Pain; Swelling/ Edema

  MAUDE report 22668439 ↗

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