Dermalon 88861742-21Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521070738), received between Nov 30, 2022 and Dec 2, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2022Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, ON AN OPEN DIAGNOSIS OF AESTHETIC BODY NONCONFORMITY DUE TO BREAST ASYMMETRY, WHEN THE SUTURE WAS OPENED FROM THE PACKAGING TO BE USED IN THE MAMMARY GLAND, THE THREAD CAME OFF THE NEEDLE. ANOTHER SUTURE OF THE SAME LOT NUMBER WAS USED. THE SURGEON WAS ABLE TO USE ON THE PATIENT FOR SUTURING USING A SIMPLE SUTURING TECHNIQUE, BUT WHEN THE SURGEON WAS PULLING AND TYING THE KNOT, THE STRAND BECAME DETACHED FROM THE NEEDLE. ANOTHER DEVICE FROM THE SAME CODE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15911629 ↗
• MalfunctionDec 1, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING OPEN SPINE SURGERY, WHEN THE SUTURE IS PULLED OUT, THE THREAD BROKE. THERE WAS A DELAY IN SURGERY. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15896350 ↗
• MalfunctionNov 30, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, ON AN OPEN DIAGNOSIS OF AESTHETIC BODY NONCONFORMITY DUE TO BREAST ASYMMETRY, WHEN THE SUTURE WAS OPENED FROM THE PACKAGING TO BE USED IN THE MAMMARY GLAND, THE THREAD CAME OFF THE NEEDLE. ANOTHER SUTURE OF THE SAME LOT NUMBER WAS USED. THE SURGEON WAS ABLE TO USE ON THE PATIENT FOR SUTURING USING A SIMPLE SUTURING TECHNIQUE, BUT WHEN THE SURGEON WAS PULLING AND TYING THE KNOT, THE STRAND BECAME DETACHED FROM THE NEEDLE. ANOTHER DEVICE FROM THE SAME CODE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15888251 ↗

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-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
• 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