HEALICOIL 72203710Recalls & reported problems
Smith & Nephew, Inc. · HEALICOIL REGENESORB 5.5 MM THREADED DILATOR, REUSABLE · Class 1
All models of HEALICOIL (20)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885554030877), received between Oct 18, 2020 and Jan 23, 2024 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Crack1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Patient Involvement1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 23, 2024Break; Break
IT WAS REPORTED THAT DURING SET UP, THE TIP OF THE HEALICOIL DILATOR´S TAP WAS BENT AND WHILE ATTEMPTING TO STRAIGHTEN IT WITH THE MOSQUITO, THE TIP ULTIMATELY SNAPPED OFF. THERE WAS NO DELAY REPORTED AND A SMITH AND NEPHEW BACK UP DEVICE WAS AVAILABLE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18565627 ↗InjuryJul 13, 2021Break; Break
IT WAS REPORTED THAT DURING PROCEDURE, THE TIP OF THE HEALICOIL PUNCH TAP BROKE OFF INTO THE PATIENT'S BONE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12162872 ↗MalfunctionOct 18, 2020Crack; Crack
IT WAS REPORTED THAT AFTER THE STERILIZATION PROCESS THE HANDLE OF THE HEALICOIL REGENESORB 5.5MM THREADED DILATOR, WAS CRACKED AND THERE WAS A BAD SMELLING OF THE HANDLE IN THE WHOLE ROOM. NO CASE WAS INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement
MAUDE report 10694724 ↗
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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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