Polysorb SL-5687GRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10884521048744), received between Jul 26, 2017 and Apr 15, 2024 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Break” (7 reports).

2 other recalls cover devices cleared under the same FDA submission (K963253, K981935); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, 3 OUT OF 12 PACKAGES HAD THE SUTURE THREAD NOT ATTACHED TO THE NEEDLE.

  Patient problems: Insufficient Information

  MAUDE report 19112572 ↗
• MalfunctionApr 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, 3 OUT OF 12 PACKAGES HAD THE SUTURE THREAD NOT ATTACHED TO THE NEEDLE.

  Patient problems: Insufficient Information

  MAUDE report 19107450 ↗
• MalfunctionApr 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, (B)(4) PACKAGES HAD THE SUTURE THREAD NOT ATTACHED TO THE NEEDLE.

  Patient problems: Insufficient Information

  MAUDE report 19107027 ↗
• MalfunctionMar 23, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROTOMY FOR HEMORRHOID CASE, WHEN REMOVED FROM THE PACKET, THE NEEDLE AND THREAD WERE BROKEN. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16601581 ↗
• MalfunctionDec 1, 2022Break; Break

  ACCORDING TO THE REPORTER, SUTURE WAS BREAKING OR BEING WEAK.

  Patient problems: Insufficient Information

  MAUDE report 15894840 ↗
• MalfunctionNov 30, 2022Break; Break

  ACCORDING TO THE REPORTER, SUTURE WAS BREAKING OR BEING WEAK.

  Patient problems: Insufficient Information

  MAUDE report 15887988 ↗
• MalfunctionAug 29, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE BROKE IN HALF IN THE PATIENT'S FACE. THE SURGEON WAS ABLE TO RETRIEVED BOTH PIECES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15317037 ↗
• MalfunctionOct 31, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING SKIN CLOSURE ON AN OPEN MOHS SURGERY, THE FIRST STRAND WAS USED, AFTER THROWING TWO SUTURES, THE NEEDLE SNAPPED IN HALF AND WAS RETRIEVED. THE SECOND STRAND WAS USED, IT ALSO BROKE AND WAS RETRIEVED BUT THERE WAS ENOUGH SUTURE TO CLOSE THE WOUND. ANOTHER STRAND WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10767302 ↗
• MalfunctionFeb 12, 2020Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE NEEDLE BROKE. ANOTHER DEVICE WAS USED.

  Patient problems: No Information

  MAUDE report 9700359 ↗
• MalfunctionOct 21, 2019Break; Break

  ACCORDING TO THE REPORTER, WHILE SUTURING ON AN OPEN PROCEDURE, THE THREADS WERE BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9216714 ↗
• MalfunctionOct 3, 2018Material Frayed; Detachment of Device or Device Component; Material Frayed; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A REPAIR OF POST SKIN CANCER REMOVAL, THE DEVICE HAD AN OUT OF BOX FAILURE, THE NEEDLES WERE COMING OFF AWAY FROM THE SUTURE AND THE SUTURES WERE FRAYING. THEY THEN USED ANOTHER DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7931067 ↗
• MalfunctionJul 26, 2017Break; Break

  ACCORDING TO THE REPORTER: OCCURRED DURING KNOT TYING DURING A SKIN LESION EXCISION. 4 ABSORBABLE SUTURES OF THE SAME LOT NUMBER BROKE. THESE SUTURES HAD BEEN OPENED OR REMOVED FROM THE PACKAGING FOR LESS THAN 5 MINUTES. ANOTHER SUTURE WAS OPENED AND USED, WITHOUT INCIDENT TO RESOLVE THE ISSUE. THERE WAS A PATIENT INVOLVED IN THIS EVENT BUT THERE WAS NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6744098 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K963253, K981935. One submission often covers many models, so check the product and lot details in each record.

• Z-2601-2018 · Jun 15, 2018 · Terminated
  Polysorb Braided Absorbable Suture 1 36" 90 cm Undyed GS-21, Product Number CL-955
• Z-2541-2017 · May 3, 2017 · Terminated
  Sutures. POLYSORB: POLSORB 0 18 U/D PRECUT 126R, Item Number: L4; POLSORB 0 18 VIO PRECUT 226T; Item Number: L14; POLSORB 0 30 VIO PRECUT 227C, Item Number: L404; POLSORB 1 18 VI