Natural Nail® 47-2495-320-11Recalls & reported problems
Zimmer, Inc. · Class 2 · Implant
All models of Natural Nail (52)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024097513), received between Nov 11, 2024 and Nov 11, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (4 reports).
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.
Reports received per month
Most reported problems
Device problems
- Tear, Rip or Hole in Device Packaging4
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 11, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20652053 ↗MalfunctionNov 11, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20652050 ↗MalfunctionNov 11, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20652049 ↗MalfunctionNov 11, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT DURING RECEIVING INSPECTION, IT WAS DISCOVERED THAT THE INNER AND OUTER PACKAGING OF THE TIBIAL NAIL WAS NOTED TO BE DAMAGED. NO PATIENT INVOLVEMENT OCCURRED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20652044 ↗
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 · TerminatedZimmer 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-0383-2010 · Jul 1, 2009 · TerminatedZimmer 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-0388-2010 · Jul 1, 2009 · TerminatedZimmer 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-0381-2010 · Jul 1, 2009 · TerminatedZimmer 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-0384-2010 · Jul 1, 2009 · TerminatedZimmer 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-0377-2010 · Jul 1, 2009 · TerminatedZimmer 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 · TerminatedZimmer 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-0378-2010 · Jul 1, 2009 · TerminatedZimmer 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-0387-2010 · Jul 1, 2009 · TerminatedZimmer 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-0385-2010 · Jul 1, 2009 · TerminatedZimmer 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-0376-2010 · Jul 1, 2009 · TerminatedZimmer 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-0386-2010 · Jul 1, 2009 · TerminatedZimmer 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-0382-2010 · Jul 1, 2009 · TerminatedZimmer 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-0379-2010 · Jul 1, 2009 · TerminatedZimmer 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 · TerminatedZimmer 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
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- TRIGEN 71674067Smith & Nephew, Inc. · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES201 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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