Natural Nail® 47-2484-035-50Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00889024094017), received between Apr 15, 2021 and Jun 5, 2024 — classified as 6 injuries, 1 malfunction.

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

17 other recalls cover devices cleared under the same FDA submission (K082770, 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJun 5, 2024Osseointegration Problem; Osseointegration Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 19467059 ↗
• InjuryMay 24, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT HAD AN INITIAL SURGERY APPROXIMATELY 2 YEARS AGO. SUBSEQUENTLY, ABOUT 8 MONTHS LATER THEY HAD A REVISION DUE TO EXIT OF THE CERVICAL SCREW FROM THE JOINT AND SINKING INTO THE ACETABULUM. DURING THE REVISION NOTED THE ACETABULAR ROOF WAS FRACTURED. ALL COMPONENTS WERE EXCHANGED WITH COMPETITOR PRODUCT. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

  Patient problems: Bone Fracture(s); Failure of Implant; Pain

  MAUDE report 19392948 ↗
• InjuryJun 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

  Patient problems: Muscle/Tendon Damage; Swelling/ Edema

  MAUDE report 17134126 ↗
• InjuryJun 15, 2023Adverse 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 TIBIAL BONE FIXATION PROCEDURE FOLLOWING A TRAUMATIC FALL WHICH RESULTED IN AN OPEN OBLIQUE FRACTURE IN THE DISTAL THIRD OF THE RIGHT KNEE. ON THE SAME DAY POSTOPERATIVELY, THE PATIENT DEVELOPED COMPARTMENT SYNDROME AND WAS RETURNED TO THE OPERATING ROOM FOR A FASCIOTOMY AND WOUND-VAC REPLACEMENT PROCEDURE TO ADDRESS THE COMPLICATIONS WITHIN THE MUSCLES. THE COMPLICATION WAS RESOLVED, FINAL CLOSURE OCCURRED AS PLANNED, AND THE PATIENT WAS DISCHARGED ONE WEEK LATER. SIX MONTH FOLLOW UP VISITS INDICATED NO SIGNS OF INFECTION OR FURTHER COMPLICATIONS, A FULL RETURN TO ACTIVITIES WITHOUT PAIN OR DIFFICULTY, AND NO COMPLICATIONS OR IMPLANT CONCERNS ON DIAGNOSTIC IMAGES. ALL AVAILABLE INFORMATION HAS BEEN REPORTED.

  Patient problems: Muscle/Tendon Damage; Swelling/ Edema

  MAUDE report 17134123 ↗
• InjuryNov 2, 2022Malposition of Device; Malposition of Device

  IT WAS REPORTED VIA A CLINICAL STUDY THAT A PATIENT UNDERWENT A LEFT TIBIAL BONE FIXATION PROCEDURE. SIXTY-SEVEN DAYS POST-IMPLANTATION, THE PATIENT EXPERIENCED OSTEOSYNTHESIS FAILURE WITH RECURVATUM MALPOSITION. SUBSEQUENTLY, THE PATIENT UNDERWENT REVISION SURGERY TO REMOVE THE MALPOSITIONED TIBIAL NAIL AND ASSOCIATED SCREWS. DUE DILIGENCE IS COMPLETE AS MULTIPLE ATTEMPTS HAVE BEEN MADE; HOWEVER NO FURTHER INFORMATION OR PRODUCT IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 15715690 ↗
• InjuryMar 15, 2022Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL OF A SCREW THAT HAD BACKED OUT APPROXIMATELY FOUR MONTHS FOLLOWING A LEG FIXATION PROCEDURE. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  MAUDE report 13769881 ↗
• MalfunctionApr 15, 2021Fracture; Fracture

  UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT.

  Patient problems: Failure of Implant

  MAUDE report 11673475 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K082770, K083497. 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-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-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-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-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-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-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-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-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
• 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-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

…and 2 more.