Natural Nail® 47-2494-380-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024097087), received between Jun 23, 2023 and Jun 23, 2023 — classified as 1 injury.

3 other recalls cover devices cleared under the same FDA submission (K101622); 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 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED APPROXIMATELY ELEVEN MONTHS POST-INITIAL IMPLANTATION DUE TO A NON-UNION FRACTURE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 17190230 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K101622. One submission often covers many models, so check the product and lot details in each record.

• Z-1467-2018 · Mar 26, 2018 · Terminated
  Zimmer Natural Nail System Tear Drop Guide Wire 3.0 mm Diameter, 70 cm length; Item Number: 47-2490-098-00
• Z-1468-2018 · Mar 26, 2018 · Terminated
  Zimmer Natural Nail System Tear Drop Guide Wire 2.4 mm Diameter, 70 cm length; Item Number: 47-2490-098-01
• Z-1469-2018 · Mar 26, 2018 · Terminated
  Zimmer Natural Nail System Tear Drop Guide Wire 3.0 mm Diameter, 100 cm Length; Item Number: 47-2490-097-00