Natural Nail® 47-2487-005-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024094666), received between Jun 15, 2023 and Jul 17, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Malposition of Device” (1 report).

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.

• InjuryJul 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT TIBIAL BONE FIXATION PROCEDURE FOLLOWING INVOLVEMENT IN A MOTOR VEHICLE ACCIDENT. SUBSEQUENTLY, FIVE (5) MONTHS POST-IMPLANTATION, IT WAS REVEALED THAT THE FRACTURE SHOWED DELAYED UNION. THE PATIENT UNDERWENT ADDITIONAL PROCEDURES TO ASSIST WITH FRACTURE FIXATION AND ADDRESS THE DELAYED HEALING. THE SURGEON HAS SINCE STATED THAT THERE IS NO CHANCE OF RECOVERY OR UNION DUE TO THE EXTENT OF THE INJURIES, AND NO REVISION IS CURRENTLY PLANNED UNTIL FURTHER REVIEW OF THE PATIENT¿S HEALING PROGRESS AT THE ONE YEAR FOLLOW UP. UPON REASSESSMENT OF THE REPORTED EVENT, THE PREVIOUSLY REPORTED TIBIAL NAIL CAP HAS BEEN DETERMINED TO BE NOT REPORTABLE. THE IMPLANTED TIBIAL NAIL IS THE DEVICE THAT ACTS AS THE UNITING MECHANISM INTENDED TO RESTORE THE NATURAL ANATOMY OF THE TIBIA WHEN TREATING TIBIAL SHAFT FRACTURES. THEREFORE, THE NAIL CAP HAS NOT CONTRIBUTED TO THE REPORTED COMPLICATION OF BONE NONUNION. THE PATIENT'S PAIN AND AMBULATION DIFFICULTIES CAN LIKEWISE BE ATTRIBUTED TO THE BONE NONUNION.

  Patient problems: Ambulation or Postural Difficulties; Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 17338468 ↗
• InjuryJun 15, 2023Malposition of Device; Malposition of Device

  NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

  Patient problems: Malunion of Bone

  MAUDE report 17134543 ↗

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-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-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-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-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-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-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-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-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-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-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-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-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
• 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