Surgilon 88861957-32Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10884521072749), received between May 11, 2017 and Feb 7, 2024 — classified as 3 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 16, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 7, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, PRIOR TO A PROCEDURE, THE SUTURE COUNT WAS WRONG; IT HAD 6 INSTEAD OF 5. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18664592 ↗
• MalfunctionApr 26, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN CRANIOTOMY PROCEDURE FOR TUMOR RESECTION, WHILE PLACING ALLODERM TO CLOSE THE DURA, THE NEEDLE WAS DETACHED TOO EASILY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14210051 ↗
• MalfunctionJun 11, 2021Break; Break

  ACCORDING TO THE REPORTER, THE NEEDLE BROKE INTO PIECES DURING DURA REPAIR OPEN PROCEDURE. ALL PIECES WERE RETRIEVED AND ANOTHER DEVICE WAS OPENED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11987809 ↗
• InjuryOct 10, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING CRANIOTOMY, WHILE CLOSING THE DURA FLAP LAYER, THE NEEDLE TIP BROKE OFF. UNABLE TO FIND THE NEEDLE TIP IN THE X-RAY AND ENDED UP TAKING PATIENT TO CT SCAN TO IDENTIFY THE NEEDLE TIP. AFTER IDENTIFYING THE NEEDLE, BROUGHT THE PATIENT BACK INTO SURGERY TO REMOVE THE NEEDLE TIP WHICH EXTENDS THE SURGICAL PROCEDURE TO 30 MINUTES OR MORE.

  Patient problems: No Code Available; Radiation Exposure, Unintended

  MAUDE report 9176793 ↗
• InjuryOct 8, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN IMAGE GUIDED CRANIOTOMY, ON SEWING THE DURA LAYER IN THE BRAIN, THE NEEDLE TIP BROKE OFF AND THEY COULD NOT FIND IT. THEY ENDED UP LOOKING FOR QUITE SOME TIME AND EVEN BROUGHT IN AN X-RAY WHICH CAME BACK NEGATIVE. IT WAS NOT FOUND OUT THAT THE NEEDLE TIP BROKE UNTIL AFTER THE SURGEON IRRIGATED THE SURGICAL SITE, SO THEY WERE NOT SURE WHERE THE NEEDLE TIP WENT. THE SURGICAL TIME WAS EXTENDED BY THIRTY MINUTES OR MORE.

  Patient problems: No Code Available; Radiation Exposure, Unintended

  MAUDE report 9165781 ↗
• MalfunctionJun 12, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING A RESECTION OF INTRACEREBELOUS TUMOR BY SUBOCCIPITAL CRAINIOTOMY PROCEDURE, THE THREAD OF THE SUTURE BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8693865 ↗
• InjuryDec 11, 2018Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A DURAL REPAIR PROCEDURE, WHILE SUTURING THE TISSUE, THE SURGEON BROKE TWO (2) NEEDLES (NEEDLE TIP) IN THE PATIENT. THE DEVICE FELL INTO THE PATIENT CAVITY, AN X-RAY WAS USED TO LOCATE THE NEEDLE. THE DEVICE WAS REPLACED BY ANOTHER MANUFACTURER'S PRODUCT TO COMPLETE THE CASE.

  Patient problems: Device Embedded In Tissue or Plaque; Radiation Exposure, Unintended

  MAUDE report 8151013 ↗
• MalfunctionNov 15, 2018Break; Break

  ACCORDING TO THE REPORTER DURING AN OPEN PROCEDURE THE NEEDLE OF THE SUTURE BROKE. ANOTHER BRAND OF SUTURE WAS USED TO COMPLETE THE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8073231 ↗
• MalfunctionNov 15, 2018Break; Break

  ACCORDING TO THE REPORTER DURING AN OPEN PROCEDURE THE NEEDLE OF THE SUTURE BROKE. ANOTHER BRAND OF SUTURE WAS USED TO COMPLETE THE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8073222 ↗
• MalfunctionSep 24, 2018Break; Break

  ACCORDING TO THE REPORTER, BOTH NEEDLE AND THREAD WERE BROKEN DURING A RESECTION TEMPORARY TUMOR IZQYUERO. THE SURGICAL TIME WAS EXTENDED FOR 30 MINUTES OR MORE DUE TO THE PRODUCT PROBLEM. THEY USED NEW SUTURE TO COMPLETE THE CASE.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 7902226 ↗
• MalfunctionSep 24, 2018Break; Break

  ACCORDING TO THE REPORTER, BOTH NEEDLE AND THREAD WERE BROKEN DURING A RESECTION TUMOR CEREBRAL. THE SURGICAL TIME WAS EXTENDED FOR 30 MINUTES OR MORE DUE TO THE PRODUCT PROBLEM. THEY USED NEW SUTURE TO COMPLETE THE CASE.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 7901882 ↗
• MalfunctionSep 24, 2018Break; Break

  ACCORDING TO THE REPORTER, BOTH NEEDLE AND THREAD WERE BROKEN DURING THE PATCH FIXATION PROCEDURE ON A BIOPSY OF DURAMADRE. THE SURGICAL TIME WAS EXTENDED FOR 30 MINUTES OR MORE DUE TO THE PRODUCT PROBLEM. THEY USED NEW SUTURE TO COMPLETE THE CASE.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 7901812 ↗
• MalfunctionAug 7, 2018Component Missing

  ACCORDING TO THE REPORTER, DURING AN OPEN NEURO PROCEDURE, THE PACKAGE HAD NO NEEDLES IN IT. A NEW SUTURE WAS OPENED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7756490 ↗
• MalfunctionMar 19, 2018Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE PACK OF THE SUTURE ONLY HAD FOUR NEEDLES INSTEAD OF FIVE. THE PATIENT STATUS WAS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7348813 ↗
• MalfunctionMay 11, 2017Break; Material Frayed; Break; Material Frayed

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE SUTURE THREAD BROKE AND WAS FRAYING . DIFFERENT SUTURE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. PATIENT STATUS - ALIVE NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6560329 ↗

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-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-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-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-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-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