Natural Nail® 47-2483-105-60Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024093799), received between Oct 4, 2021 and Oct 4, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (1 report).

16 other recalls cover devices cleared under the same FDA submission (K083497); 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.

• MalfunctionOct 4, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT DURING A PROCEDURE APPROXIMATELY THREE WEEKS AGO, THE SURGEON OPENED THE OUTER PACKAGING OF THE SCREW TO DISCOVER THE SCREW BROKEN THROUGH THE INNER STERILE PACKAGING. SURGEON USED A BACKUP SCREW TO COMPLETE THE SURGERY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12569027 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083497. One submission often covers many models, so check the product and lot details in each record.

• Z-2599-2017 · Apr 28, 2017 · Terminated
  Z NAIL PF 14MM X 46CM UNIV Z NAIL GT 14MM X 46CM R Z NAIL GT 14MM X 46CM L Z NAIL TIBIA 14MM X 38CM UNIV Z NAIL TIBIA 14MM X 40CM UNIV Z NAIL TIBIA 14MM X 42CM UNIV Z NAIL TIBIA 14
• Z-2060-2015 · Jun 17, 2015 · Terminated
  ZNN Antegrade Femoral Nail (ZNN AF). Orthopedic internal fixation device.
• 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-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-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-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-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-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-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-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-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-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-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-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

…and 1 more.