Surgilon 88861917-71Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521071612), received between Feb 1, 2018 and Oct 23, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (5 reports).

9 other recalls cover devices cleared under the same FDA submission (K981582); 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 23, 2023Break; Break

  ACCORDING TO THE REPORTER, PREOPERATIVELY, A PIECE OF SUTURE CAME OUT WHEN THE PACKAGE WAS OPENED. ANOTHER NEW SUTURE WAS USED WITHOUT ANY PROBLEM. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17986672 ↗
• MalfunctionDec 17, 2021Break; Break

  ACCORDING TO THE REPORTER, PRE OPERATIVELY, ON A POSTERIOR LUMBAR VERTEBRAL BODY FIXATION, THE BROKEN END OF THE 2 THREADS WERE FOUND TO BE MIXED WHEN IT WAS OPENED ON THE DEVICE TABLE. THE OPERATOR STOPPED USING THE SUTURE AND GOT A NEW ONE THAT WAS UTILIZED WITHOUT ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13024764 ↗
• MalfunctionSep 15, 2021Break; Break

  ACCORDING TO THE REPORTER, PRE OPERATIVELY, ON A POSTERIOR LUMBAR VERTEBRAL BODY FIXATION, THE BROKEN END OF THE 2 THREADS WERE FOUND TO BE MIXED WHEN IT WAS OPENED ON THE DEVICE TABLE. THE OPERATOR STOPPED USING THE SUTURE AND GOT A NEW ONE THAT WAS UTILIZED WITHOUT ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12474756 ↗
• MalfunctionJul 2, 2018Break; Break

  ACCORDING TO THE REPORTER, PRE OPERATIVELY, THE CORE SUTURE WAS SEPARATED FROM THE THREAD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7654625 ↗
• MalfunctionJun 20, 2018Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE CORE THREADS OF ALL THE PRODUCTS WERE EXPOSED AS MUCH AS 3 MM. THE EVENT OCCURRED DURING THE PROCEDURE BUT THE PRODUCT WAS NOT USED FOR PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7621793 ↗
• MalfunctionFeb 1, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE SUTURING, THE THREAD BROKE EASILY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7234825 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K981582. One submission often covers many models, so check the product and lot details in each record.

• Z-2920-2026 · Jun 24, 2026 · Open, Classified
  Dermalon 88861757-31 DERMALON* 4-0 BLU 75CM C13 88861757-31 88861799-31 DERMALON* 4-0 BLU 75CM C14 88861799-31
• Z-0844-2024 · Dec 21, 2023 · Open, Classified
  Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT 88861919-51 SURGILON* 2-0 BLK 7X75CMPCT 88861919-71 SURGILON* 1 BLK
• Z-1178-2023 · Dec 2, 2022 · Open, Classified
  Surgilon Braided Nylon suture Product Description: 88861883-51 SURGILON* 2-0 BLK 75CM C16 88861915-71 SURGILON* 1 BLK 75CM GS11 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41
• Z-1172-2023 · Dec 2, 2022 · Open, Classified
  Dermalon Monofilament Nylon Suture: (1) 88861741-11 DERMALON* 6-0 BLU 45CM C1 (2) 88861747-11 DERMALON* 6-0 BLU 45CM C12 (3) 88861749-24 DERMALON* 5-0 BLU 45CM P13 (4) 88861756-11
• Z-2823-2011 · Jun 3, 2011 · Terminated
  Syneture Surgilon 0 Black 5X18 T-3/GS-23 D-TACH non-absorbable braided nylon sutures Material 8886199362 Surgilon is intended for use in general soft tissue approximation and/or l
• Z-2824-2011 · Jun 3, 2011 · Terminated
  Syneture Surgilon 4/0 BLK 5X18 CV-22 D*TACH JLDT non-absorbable braided nylon sutures Material 8886195332J Surgilon is intended for use in general soft tissue approximation and/or
• Z-2820-2011 · Jun 3, 2011 · Terminated
  Syneture Surgilon 5/0 Blk 5X18 T-37/CV-20 D-TACH non-absorbable braided nylon sutures Material 8886191022 Surgilon is intended for use in general soft tissue approximation and
• Z-2821-2011 · Jun 3, 2011 · Terminated
  Syneture Surgilon 0 Blk 3X18 CE-10/C-16 non-absorbable braided nylon sutures Material 8886193662 Surgilon is intended for use in general soft tissue approximation and/or ligation
• Z-2822-2011 · Jun 3, 2011 · Terminated
  Syneture Surgilon 0 Blk 5X18 T-12/GS-21 D-TACH non-absorbable braided nylon sutures Material 8886196262 Surgilon is intended for use in general soft tissue approximation and/or