UNIFY Polyester Surgical Sutures L-E230R24Recalls & reported problems
Applied Dental, Inc. · UNIFY Polyester Surgical Sutures, LG 2-0, 24mm 3/8 Circle Rev Cut, 30" · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 16
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00814639021141), received between Jul 7, 2021 and Jul 7, 2021 — classified as 16 malfunctions.
The most frequently reported specific device problem is “Biocompatibility” (16 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.
Most reported problems
Device problems
- Biocompatibility16
Patient problems
- Unspecified Infection15
- Insufficient Information1
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 7, 2021Biocompatibility; Biocompatibility
(B)(6) PATIENT RETURNED CLINIC WITH INFECTION ISSUE AFTER THE MINI-FACELIFT SURGERY, AND ALL THEY USED POLYESTER 2/0 SUTURE WITH THE SAME LOT. PER NURSE WHO WORKS IN THAT CLINIC DESCRIPTION, THE INFECTION OCCURRED AT DIFFERENT TIME WITHIN THE FIRST SEVERAL WEEKS. SOME PATIENTS NEED TO REOPEN AND REMOVE THE SUTURE. THE CLINIC TREATED THE PATIENTS WITH ANTIBIOTICS, AND THEY BEGAN TO HEAL.
Patient problems: Unspecified Infection
MAUDE report 12126392 ↗MalfunctionJul 7, 2021Biocompatibility; Biocompatibility
7 PATIENT RETURNED CLINIC WITH INFECTION ISSUE AFTER THE MINI-FACELIFT SURGERY, AND ALL THEY USED POLYESTER 2/0 SUTURE WITH THE SAME LOT. PER NURSE WHO WORKS IN THAT CLINIC DESCRIPTION, THE INFECTION OCCURRED AT DIFFERENT TIME WITHIN THE FIRST SEVERAL WEEKS. SOME PATIENTS NEED TO REOPEN AND REMOVE THE SUTURE. THE CLINIC TREATED THE PATIENTS WITH ANTIBIOTICS, AND THEY BEGAN TO HEAL.
Patient problems: Unspecified Infection
MAUDE report 12126390 ↗MalfunctionJul 7, 2021Biocompatibility; Biocompatibility
7 PATIENT RETURNED CLINIC WITH INFECTION ISSUE AFTER THE MINI-FACELIFT SURGERY, AND ALL THEY USED POLYESTER 2/0 SUTURE WITH THE SAME LOT. PER NURSE WHO WORKS IN THAT CLINIC DESCRIPTION, THE INFECTION OCCURRED AT DIFFERENT TIME WITHIN THE FIRST SEVERAL WEEKS. SOME PATIENTS NEED TO REOPEN AND REMOVE THE SUTURE. THE CLINIC TREATED THE PATIENTS WITH ANTIBIOTICS, AND THEY BEGAN TO HEAL.
Patient problems: Unspecified Infection
MAUDE report 12126358 ↗MalfunctionJul 7, 2021Biocompatibility; Biocompatibility
7 PATIENT RETURNED CLINIC WITH INFECTION ISSUE AFTER THE MINI-FACELIFT SURGERY, AND ALL THEY USED POLYESTER 2/0 SUTURE WITH THE SAME LOT. PER NURSE WHO WORKS IN THAT CLINIC DESCRIPTION, THE INFECTION OCCURRED AT DIFFERENT TIME WITHIN THE FIRST SEVERAL WEEKS. SOME PATIENTS NEED TO REOPEN AND REMOVE THE SUTURE. THE CLINIC TREATED THE PATIENTS WITH ANTIBIOTICS, AND THEY BEGAN TO HEAL.
Patient problems: Unspecified Infection
MAUDE report 12126354 ↗MalfunctionJul 7, 2021Biocompatibility; Biocompatibility
7 PATIENT RETURNED CLINIC WITH INFECTION ISSUE AFTER THE MINI-FACELIFT SURGERY, AND ALL THEY USED POLYESTER 2/0 SUTURE WITH THE SAME LOT. PER NURSE WHO WORKS IN THAT CLINIC DESCRIPTION, THE INFECTION OCCURRED AT DIFFERENT TIME WITHIN THE FIRST SEVERAL WEEKS. SOME PATIENTS NEED TO REOPEN AND REMOVE THE SUTURE. THE CLINIC TREATED THE PATIENTS WITH ANTIBIOTICS, AND THEY BEGAN TO HEAL.
Patient problems: Unspecified Infection
MAUDE report 12126351 ↗MalfunctionJul 7, 2021Biocompatibility; Biocompatibility
7 PATIENT RETURNED CLINIC WITH INFECTION ISSUE AFTER THE MINI-FACELIFT SURGERY, AND ALL THEY USED POLYESTER 2/0 SUTURE WITH THE SAME LOT. PER NURSE WHO WORKS IN THAT CLINIC DESCRIPTION, THE INFECTION OCCURRED AT DIFFERENT TIME WITHIN THE FIRST SEVERAL WEEKS. SOME PATIENTS NEED TO REOPEN AND REMOVE THE SUTURE. THE CLINIC TREATED THE PATIENTS WITH ANTIBIOTICS, AND THEY BEGAN TO HEAL.
Patient problems: Insufficient Information
MAUDE report 12126344 ↗MalfunctionJul 7, 2021Biocompatibility; Biocompatibility
7 PATIENT RETURNED CLINIC WITH INFECTION ISSUE AFTER THE MINI-FACELIFT SURGERY, AND ALL THEY USED POLYESTER 2/0 SUTURE WITH THE SAME LOT. PER NURSE WHO WORKS IN THAT CLINIC DESCRIPTION, THE INFECTION OCCURRED AT DIFFERENT TIME WITHIN THE FIRST SEVERAL WEEKS. SOME PATIENTS NEED TO REOPEN AND REMOVE THE SUTURE. THE CLINIC TREATED THE PATIENTS WITH ANTIBIOTICS, AND THEY BEGAN TO HEAL.
Patient problems: Unspecified Infection
MAUDE report 12126342 ↗MalfunctionJul 7, 2021Biocompatibility; Biocompatibility
7 PATIENT RETURNED CLINIC WITH INFECTION ISSUE AFTER THE MINI-FACELIFT SURGERY, AND ALL THEY USED POLYESTER 2/0 SUTURE WITH THE SAME LOT. PER NURSE WHO WORKS IN THAT CLINIC DESCRIPTION, THE INFECTION OCCURRED AT DIFFERENT TIME WITHIN THE FIRST SEVERAL WEEKS. SOME PATIENTS NEED TO REOPEN AND REMOVE THE SUTURE. THE CLINIC TREATED THE PATIENTS WITH ANTIBIOTICS, AND THEY BEGAN TO HEAL.
Patient problems: Unspecified Infection
MAUDE report 12126293 ↗MalfunctionJul 7, 2021Biocompatibility; Biocompatibility
(B)(6) PATIENT RETURNED CLINIC WITH INFECTION ISSUE AFTER THE MINI-FACELIFT SURGERY, AND ALL THEY USED POLYESTER 2/0 SUTURE WITH THE SAME LOT. PER NURSE WHO WORKS IN THAT CLINIC DESCRIPTION, THE INFECTION OCCURRED AT DIFFERENT TIME WITHIN THE FIRST SEVERAL WEEKS. SOME PATIENTS NEED TO REOPEN AND REMOVE THE SUTURE. THE CLINIC TREATED THE PATIENTS WITH ANTIBIOTICS, AND THEY BEGAN TO HEAL.
Patient problems: Unspecified Infection
MAUDE report 12126289 ↗MalfunctionJul 7, 2021Biocompatibility; Biocompatibility
7 PATIENT RETURNED CLINIC WITH INFECTION ISSUE AFTER THE MINI-FACELIFT SURGERY, AND ALL THEY USED POLYESTER 2/0 SUTURE WITH THE SAME LOT. PER NURSE WHO WORKS IN THAT CLINIC DESCRIPTION, THE INFECTION OCCURRED AT DIFFERENT TIME WITHIN THE FIRST SEVERAL WEEKS. SOME PATIENTS NEED TO REOPEN AND REMOVE THE SUTURE. THE CLINIC TREATED THE PATIENTS WITH ANTIBIOTICS, AND THEY BEGAN TO HEAL.
Patient problems: Unspecified Infection
MAUDE report 12126288 ↗MalfunctionJul 7, 2021Biocompatibility; Biocompatibility
(B)(6) PATIENT RETURNED CLINIC WITH INFECTION ISSUE AFTER THE MINI-FACELIFT SURGERY, AND ALL THEY USED POLYESTER 2/0 SUTURE WITH THE SAME LOT. PER NURSE WHO WORKS IN THAT CLINIC DESCRIPTION, THE INFECTION OCCURRED AT DIFFERENT TIME WITHIN THE FIRST SEVERAL WEEKS. SOME PATIENTS NEED TO REOPEN AND REMOVE THE SUTURE. THE CLINIC TREATED THE PATIENTS WITH ANTIBIOTICS, AND THEY BEGAN TO HEAL.
Patient problems: Unspecified Infection
MAUDE report 12126279 ↗MalfunctionJul 7, 2021Biocompatibility; Biocompatibility
7 PATIENT RETURNED CLINIC WITH INFECTION ISSUE AFTER THE MINI-FACELIFT SURGERY, AND ALL THEY USED POLYESTER 2/0 SUTURE WITH THE SAME LOT. PER NURSE WHO WORKS IN THAT CLINIC DESCRIPTION, THE INFECTION OCCURRED AT DIFFERENT TIME WITHIN THE FIRST SEVERAL WEEKS. SOME PATIENTS NEED TO REOPEN AND REMOVE THE SUTURE. THE CLINIC TREATED THE PATIENTS WITH ANTIBIOTICS, AND THEY BEGAN TO HEAL.
Patient problems: Unspecified Infection
MAUDE report 12126276 ↗MalfunctionJul 7, 2021Biocompatibility; Biocompatibility
7 PATIENT RETURNED CLINIC WITH INFECTION ISSUE AFTER THE MINI-FACELIFT SURGERY, AND ALL THEY USED POLYESTER 2/0 SUTURE WITH THE SAME LOT. PER NURSE WHO WORKS IN THAT CLINIC DESCRIPTION, THE INFECTION OCCURRED AT DIFFERENT TIME WITHIN THE FIRST SEVERAL WEEKS. SOME PATIENTS NEED TO REOPEN AND REMOVE THE SUTURE. THE CLINIC TREATED THE PATIENTS WITH ANTIBIOTICS, AND THEY BEGAN TO HEAL.
Patient problems: Unspecified Infection
MAUDE report 12126270 ↗MalfunctionJul 7, 2021Biocompatibility; Biocompatibility
7 PATIENT RETURNED CLINIC WITH INFECTION ISSUE AFTER THE MINI-FACELIFT SURGERY, AND ALL THEY USED POLYESTER 2/0 SUTURE WITH THE SAME LOT. PER NURSE WHO WORKS IN THAT CLINIC DESCRIPTION, THE INFECTION OCCURRED AT DIFFERENT TIME WITHIN THE FIRST SEVERAL WEEKS. SOME PATIENTS NEED TO REOPEN AND REMOVE THE SUTURE. THE CLINIC TREATED THE PATIENTS WITH ANTIBIOTICS, AND THEY BEGAN TO HEAL.
Patient problems: Unspecified Infection
MAUDE report 12126269 ↗MalfunctionJul 7, 2021Biocompatibility; Biocompatibility
7 PATIENT RETURNED CLINIC WITH INFECTION ISSUE AFTER THE MINI-FACELIFT SURGERY, AND ALL THEY USED POLYESTER 2/0 SUTURE WITH THE SAME LOT. PER NURSE WHO WORKS IN THAT CLINIC DESCRIPTION, THE INFECTION OCCURRED AT DIFFERENT TIME WITHIN THE FIRST SEVERAL WEEKS. SOME PATIENTS NEED TO REOPEN AND REMOVE THE SUTURE. THE CLINIC TREATED THE PATIENTS WITH ANTIBIOTICS, AND THEY BEGAN TO HEAL.
Patient problems: Unspecified Infection
MAUDE report 12126238 ↗MalfunctionJul 7, 2021Biocompatibility; Biocompatibility
7 PATIENT RETURNED CLINIC WITH INFECTION ISSUE AFTER THE MINI-FACELIFT SURGERY, AND ALL THEY USED POLYESTER 2/0 SUTURE WITH THE SAME LOT. PER NURSE WHO WORKS IN THAT CLINIC DESCRIPTION, THE INFECTION OCCURRED AT DIFFERENT TIME WITHIN THE FIRST SEVERAL WEEKS. SOME PATIENTS NEED TO REOPEN AND REMOVE THE SUTURE. THE CLINIC TREATED THE PATIENTS WITH ANTIBIOTICS, AND THEY BEGAN TO HEAL.
Patient problems: Unspecified Infection
MAUDE report 12126230 ↗
Other Suture, Nonabsorbable, Synthetic, Polyethylene devices
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- FAST-FIX 72205676Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE439 reports
- Arthrex® AR-4501Arthrex, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE403 reports
- FAST-FIX 72205324Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE383 reports
- LUPINE ORTHOCORD 210712Medos International Sàrl · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE357 reports
- FAST-FIX 72201494Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE249 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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