FORCE FIBER IPN000976Recalls & reported problems
Teleflex Incorporated · Force Fiber White Braided Size 5 36" K-60 Needle Tornier · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 14026704608666), received between Apr 28, 2026 and Apr 28, 2026 — classified as 1 malfunction.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Granuloma1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 28, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT "INFLAMMATORY GRANULOMA AT THE SITE WITH WOUND DEHISCENCE. STAPHYLOCOCCUS AUREUS INFECTION. THE PATIENT'S CURRENT CONDITION: GRANULOMA AND INFECTION; TREATMENT INCLUDED MANAGEMENT OF THE INFECTION, RETURN TO THE OPERATING ROOM, AND ANTIBIOTIC THERAPY. THE PATIENT HAS NOW FULLY RECOVERED. ACTIONS TAKEN INCLUDED REMOVAL OF SCREWS, DEBRIDEMENT OF SUTURES, AND DEBRIDEMENT OF BONE AND SOFT TISSUE. WE DO NOT ATTRIBUTE THE INFECTION SOLELY TO YOUR SUTURE MATERIAL; HOWEVER, WE REPORTED IT FOR ALL THE SUTURES THIS PATIENT RECEIVED BECAUSE WE DO NOT KNOW EXACTLY WHERE THE INFECTION ORIGINATED."
Patient problems: Granuloma
MAUDE report 25023861 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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