Zimmer® Natural Nail® System 47-2485-095-10Recalls & reported problems
Zimmer GmbH · ZNN CMN LAG SCREW 10.5X95 · Class 2 · Implant
All models of Zimmer Natural Nail System (57)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00889024298446), received between Feb 26, 2019 and Jul 9, 2024 — classified as 5 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Fracture” (4 reports).
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
- Fracture4
- Adverse Event Without Identified Device or Use Problem2
- Break1
- Contamination /Decontamination Problem1
- Difficult to Insert1
- Insufficient Device Problem Information1
- Material Integrity Problem1
- Mechanical Jam1
Patient problems
- Failure of Implant3
- No Clinical Signs, Symptoms or Conditions3
- Hemorrhage/Blood Loss/Bleeding1
- Insufficient Information1
- No Known Impact Or Consequence To Patient1
- Nonunion/Delayed-union Bone Fracture1
- Pain1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
InjuryJul 9, 2024Difficult to Insert; Difficult to Insert
NO ADDITIONAL EVENT INFORMATION AT THIS TIME.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 19701990 ↗InjuryJul 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
MalfunctionFeb 21, 2023Mechanical Jam; Mechanical Jam
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16406736 ↗MalfunctionFeb 9, 2022Contamination /Decontamination Problem; Adverse Event Without Identified Device or Use Problem; Contamination /Decontamination Problem; Adverse Event Without Identified Device or Use Problem
IT WAS NOTICED THAT THE PACKAGING WAS DAMAGED AND STERILITY WAS NOT GIVEN ANYMORE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13498167 ↗MalfunctionJan 24, 2022Break; Fracture; Break; Fracture
IT WAS REPORTED THAT: SURGEON REPORTED LAG SCREW ANTI-ROTATION TABS BROKE OFF DURING INSERTION OF LAG SCREW INTO FEMORAL HEAD. THE FACILITY SAYS LAG SCREW INSERTER IS STILL GOOD. THERE WERE NO REMAINING PIECES THAT BROKE OFF OF THE LAG SCREW PER SURGEON ALL SMALL PIECES WERE REMOVED AND LAG SCREW REMAINED IMPLANTED PER SURGEON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13334177 ↗InjuryJan 20, 2022Fracture; Material Integrity Problem; Fracture; Material Integrity Problem
IT WAS REPORTED THAT THERE WAS A FRACTURE OF THE "WINGS" AT ME OF THE FEMORAL NECK SCREW. OP TIME EXTENSION BY APPROX. 120-150MIN.
Patient problems: Failure of Implant
MAUDE report 13305549 ↗InjuryApr 21, 2021Fracture; Fracture
NO EVENT UPDATE. INVESTIGATION RESULTS ARE NOW AVAILABLE.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 11699395 ↗MalfunctionApr 23, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT, DURING THE INITIAL SURGERY, THERE WAS AN ASSEMBLING PROBLEM WITH THE SET SCREW TO THE LAG SCREW. IT WAS STATED THAT THE TIP OF THE SET SCREW WAS FRACTURED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8539370 ↗InjuryFeb 26, 2019Fracture; Fracture
PLEASE REFER TO REPORT 0009613350-2019-00090.
Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture
MAUDE report 8370156 ↗
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- PRECICE® Intramedullary Limb Lengthening System LSC5-075Nuvasive Specialized Orthopedics, Inc. · Rod, Fixation, Intramedullary And Accessories4 recalls2 reports
- PRECICE® Intramedullary Limb Lengthening System LSC5-045Nuvasive Specialized Orthopedics, Inc. · Rod, Fixation, Intramedullary And Accessories4 recalls1 report
- PRECICE® Intramedullary Limb Lengthening System LSC5-050Nuvasive Specialized Orthopedics, Inc. · Rod, Fixation, Intramedullary And Accessories4 recalls1 report
- TRIGEN 71674067Smith & Nephew, Inc. · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES201 reports
- PRECICE Intramedullary Limb Lengthening System LSB5-040Nuvasive Specialized Orthopedics, Inc. · Rod, Fixation, Intramedullary And Accessories4 recalls0 reports
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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