Natural Nail® 47-2495-380-09Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024097704), received between Oct 11, 2022 and May 24, 2024 — classified as 2 injuries.

15 other recalls cover devices cleared under the same FDA submission (K082770); 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.

• InjuryMay 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP SURGERY ON AND UNKNOWN DATE. SUBSEQUENTLY, IT HAS BEEN RECOMMENDED THAT THE PATIENT UNDERGO A REVISION SURGERY DUE A DELAY IN THE HEALING OF THE PATIENT'S BONE. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION, BUT NO ADDITIONAL INFORMATION HAS BEEN OBTAINED AT THIS TIME.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 19393359 ↗
• InjuryOct 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA A CLINICAL STUDY THAT A PATIENT UNDERWENT A BONE FIXATION PROCEDURE. ON AN UNKNOWN TIME FRAME POST-IMPLANTATION, THE PATIENT EXPERIENCED PSEUDOARTHROSIS. SUBSEQUENTLY, THE PATIENT UNDERWENT REVISION SURGERY OF THE TIBIAL NAIL WITH OVER-DRILLING AND RE-OSTEOSYNTHESIS. DUE DILIGENCE IS IN PROGRESS FOR THIS EVENT; TO DATE NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 15579353 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K082770. One submission often covers many models, so check the product and lot details in each record.

• Z-3246-2018 · Jul 30, 2018 · Terminated
  Zimmer Natural Nail Tibial Nail - Yellow 8.3mm, Model Number 47249534008 Product Usage - The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilizati
• Z-0385-2010 · Jul 1, 2009 · Terminated
  Zimmer Natural Nail System, Antegrade Femoral Interlock Module, small, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-008-03. The device is used to drill into the proximal tibia or d
• Z-0378-2010 · Jul 1, 2009 · Terminated
  Zimmer Natural Nail System, Tibial Targeting Guide Handle, small, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-005-00. The device is used to drill into the proximal tibia or distal
• Z-0384-2010 · Jul 1, 2009 · Terminated
  Zimmer Natural Nail System, Antegrade Femoral interlock Module, tall, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-001-53. The device is used to drill into the proximal tibia or di
• Z-0379-2010 · Jul 1, 2009 · Terminated
  Zimmer Natural Nail System, Tibial Targeting Guide Handle, tall, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-005-03. The device is used to drill into the proximal tibia or distal
• Z-0380-2010 · Jul 1, 2009 · Terminated
  Zimmer Natural Nail System, Antegrade Femoral Targeting Guide Handle, small, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-008-00. The device is used to drill into the proximal tibi
• Z-0376-2010 · Jul 1, 2009 · Terminated
  Zimmer Natural Nail System, Antegrade Femoral Targeting Guide Handle, tall, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-001-05. The device is used to drill into the proximal tibia
• Z-0381-2010 · Jul 1, 2009 · Terminated
  Zimmer Natural Nail System, Antegrade Femoral Targeting Guide Handle, small, 0.512" wide, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-008-10. The device is used to drill into the
• Z-0388-2010 · Jul 1, 2009 · Terminated
  Zimmer Natural Nail System, Connecting Knob, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-000-11. The device is used to drill into the proximal tibia or distal femur for placement
• Z-0375-2010 · Jul 1, 2009 · Terminated
  Zimmer Natural Nail System, Antegrade Femoral Targeting Guide Handle, standard, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-001-00. The device is used to drill into the proximal t
• Z-0386-2010 · Jul 1, 2009 · Terminated
  Zimmer Natural Nail System, Antegrade Femoral Recon Module, small, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-008-08. The device is used to drill into the proximal tibia or dista
• Z-0377-2010 · Jul 1, 2009 · Terminated
  Zimmer Natural Nail System, Antegrade Femoral Targeting Guide Handle, standard, 0.512" wide, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-001-10. The device is used to drill into t
• Z-0387-2010 · Jul 1, 2009 · Terminated
  Zimmer Natural Nail System, Tibial Module, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-005-04. The device is used to drill into the proximal tibia or distal femur for placement of
• Z-0382-2010 · Jul 1, 2009 · Terminated
  Zimmer Natural Nail System, Antegrade Femoral Interlock Module, standard, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-001-03. The device is used to drill into the proximal tibia o
• Z-0383-2010 · Jul 1, 2009 · Terminated
  Zimmer Natural Nail System, Antegrade Femoral Recon Module, standard, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-001-08. The device is used to drill into the proximal tibia or di