Polysorb SL-693Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 10884521049246), received between Jan 30, 2019 and Sep 21, 2026 — classified as 5 injuries, 43 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (23 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 25 most recent of 48 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Detachment of Device or Device Component

  According to the reporter, during a procedure, when using the suture, the needle and thread detached. The product was replaced to resolve the issue. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50841042 ↗
• MalfunctionSep 18, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50826262 ↗
• MalfunctionSep 18, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50825974 ↗
• MalfunctionSep 18, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50825638 ↗
• MalfunctionSep 18, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50825213 ↗
• MalfunctionSep 18, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50824819 ↗
• MalfunctionSep 18, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50824490 ↗
• MalfunctionSep 18, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50824148 ↗
• MalfunctionSep 18, 2026Break

  Patient problems: Insufficient Information

  MAUDE report 50820924 ↗
• MalfunctionSep 18, 2026Break

  According to the reporter, during a procedure, the suture was damaged when the pack was opened. A new suture was used to resolve the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50818122 ↗
• MalfunctionFeb 9, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, IN AN OPEN BREAST SURGERY, WHILE SUTURING THE SKIN, THE NEEDLE DETACHED FROM THE THREAD.

  Patient problems: Insufficient Information

  MAUDE report 24293635 ↗
• MalfunctionOct 21, 2025Device Slipped; Device Slipped

  ACCORDING TO THE REPORTER DURING A DEBRIDEMENT AND SUTURING FOR THE PATIENT, DURING KNOT TYING, SLIPPAGE OCCURRED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23345588 ↗
• MalfunctionSep 18, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE BEFORE PATIENT USE, WHEN THE PACKAGE WAS OPENED AND PLACED THE SUTURE ON THE STERILE OPERATING TABLE, AND WHEN PREPARING TO SUTURE, THE THREAD BROKE AS SOON AS IT WAS PULLED. A NEW SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 23092502 ↗
• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER DURING A CESAREAN SECTION, WOUND DEHISCENCE OCCURRED WHILE SUTURING THE WOUND WITH SYNTHETIC ABSORBABLE SURGICAL SUTURES. NEW POLYGLYCOLIC ACID ABSORBABLE SUTURES WERE IMMEDIATELY USED TO CONTINUE SUTURING, ALLOWING THE CESAREAN SECTION TO BE COMPLETED. HOWEVER DUE TO THE WOUND DEHISCENCE, REPEATED SUTURING WAS REQUIRED WHICH PROLONGED THE PATIENT'S HOSPITAL STAY.

  Patient problems: Tissue Breakdown; Wound Dehiscence

  MAUDE report 22964351 ↗
• InjuryNov 14, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, POST OPERATIVE A RIGHT TIBIA AND FIBULA FRACTURE OPEN REDUCTION AND INTERNAL FIXATION (REMOVAL OF INTERNAL FIXATION DEVICE) ON THE FOURTH DAY AFTER THE INITIAL PROCEDURE, THE PATIENT'S INCISION WAS FOUND TO HAVE REDNESS AND SWELLING OF THE SKIN AND POOR HEALING. THE SUTURE WAS THEN REMOVED. AFTER THE SYNTHETIC ABSORBABLE SURGICAL SUTURES WERE REMOVED, CEFUROXIME INJECTION 1.5G TWICE A DAY AND DAILY CLEANING AND DRESSING WERE CONTINUED. SUBSEQUENT ROUNDS REVEALED THAT THE PATIENT'S ADVERSE REACTION SYMPTOMS TENDED TO DISAPPEAR AND THE WOUND WAS GRADUALLY HEALING, BUT SHE STILL NEEDED TO EXTEND HOSPITALIZATION FOR OBSERVATION.

  Patient problems: Impaired Healing; Skin Inflammation/ Irritation

  MAUDE report 20682823 ↗
• MalfunctionOct 1, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE WAS A SINGLE NEEDLE SUTURE WITH DOUBLE NEEDLES. A NEW FOIL WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20346968 ↗
• InjurySep 11, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, AFTER A RIGHT PLANTAR TUMOR RESECTION PROCEDURE, A SMALL AMOUNT OF PURULENT EXUDATION APPEARED IN THE INCISION ON THE SECOND DAY FOLLOWING THE SURGERY. THE SUTURE WAS REMOVED, AND DRAINAGE WAS PERFORMED. ON THE THIRD DAY AFTER THE SURGERY, THE DRESSING WAS CHANGED, AND THE INCISION WAS CLEAN AND FREE OF EXUDATION. HOWEVER, PURULENT EXUDATION REAPPEARED DURING DRESSING CHANGE. BACTERIAL CULTURE WAS PERFORMED, AND RESIDUAL SUTURES WERE FOUND IN THE INCISION AND REMOVED. ON THE 10TH AND 12TH DAYS FOLLOWING THE SURGERY, THE DRESSING CHANGES SHOWED THAT THE WOUND WAS DRY AND CLEAN WITH NO EXUDATION. THE INCISION HAD HEALED COMPLETELY, AND THERE WAS NO REDNESS, SWELLING, OR TENDERNESS AROUND IT.

  Patient problems: Purulent Discharge

  MAUDE report 20194329 ↗
• MalfunctionJun 3, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A QUADRANTECTOMY OF THE BREAST, WHILE SUTURING THE TISSUE USING THE ABSORBABLE SUTURE, THE FRONT END OF THE NEEDLE TIP BROKE APPROXIMATELY 0.2 CM AWAY. AFTER SEARCHING THROUGH VARIOUS PARTIES, IT WAS FOUND ON THE CUT SPECIMEN TISSUE. IT INCREASED THE WORKLOAD OF THE OPERATING SURGEONS AND OPERATING ROOM NURSES. SURGICAL TIME WAS EXTENDED BY FIVE MINUTES. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19445143 ↗
• MalfunctionApr 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVELY, WHEN FIRST UNPACKING THE PACKAGE AND PREPARING TO USE THE SUTURE, THE NEEDLE AND SUTURE WERE DETACHED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19021381 ↗
• MalfunctionMar 26, 2024Product Quality Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Product Quality Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING THE SUTURING OF THE EPISIOTOMY, WHEN SUTURING THE SUBCUTANEOUS TISSUE IT WAS FOUND THAT THE NEEDLE WAS TOO THIN, THE ARC LENGTH WAS 2MM SHORT, AND THE SUTURE WAS TOO THICK AND TOO HARD. DURING A POSTPARTUM VISIT, THE PATIENT COMPLAINED OF SLIGHT PAIN THE WOUND, WAS ANXIOUS, THAT THE WOUND WOULD NOT GROW WELL. THE PHYSICAL EXAMINATION REVEALED THAT THE SUTURE KNOT WAS NOT ABSORBED, AND AFTER INVESTIGATION, IT TOOK 14 DAYS FOR THE SUTURE TO BE HYDROLYZED AND ABSORBED. THE PATIENT'S WOUND RECOVERY WAS TRACKED, CONTINUED TO OBSERVE, GUIDED PREGNANT WOMEN TO EAT MORE HIGH-PROTEIN FOODS, AND KEPT THE WOUND CLEAN AND DRY.

  Patient problems: Anxiety; Pain

  MAUDE report 18980501 ↗
• MalfunctionDec 27, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PELVIC FLOOR MUSCLE SUTURING, WHEN PREPARING THE DEVICE, THE NEEDLE AND THREAD SEPARATED ON BOTH DEVICE. ANOTHER DEVICE FROM ANOTHER LOT NO. WAS USED HOWEVER THE ISSUE PERSISTS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18407149 ↗
• MalfunctionDec 27, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PELVIC FLOOR MUSCLE SUTURING, WHEN PREPARING THE DEVICE, THE NEEDLE AND THREAD SEPARATED ON BOTH DEVICE. ANOTHER DEVICE FROM ANOTHER LOT NO. WAS USED HOWEVER THE ISSUE PERSISTS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18407062 ↗
• MalfunctionDec 27, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PELVIC FLOOR MUSCLE SUTURING, WHEN PREPARING THE DEVICE, THE NEEDLE AND THREAD SEPARATED ON BOTH DEVICE. ANOTHER DEVICE FROM ANOTHER LOT NO. WAS USED HOWEVER THE ISSUE PERSISTS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18405423 ↗
• MalfunctionDec 22, 2023Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING A PELVIC FLOOR MUSCLE PROCEDURE, WHILE PREPARING FOR CONTINUOUS SUTURING, THE NEEDLE AND THE THREAD DETACHED. A COMPETITOR'S SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18384908 ↗
• MalfunctionSep 14, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN CESAREAN SECTION PROCEDURE, A PROBLEM OCCURRED WHILE APPLYING THE SUTURE DURING SKIN CLOSURE. THE NEEDLE AND SUTURE DETACHED. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17746337 ↗

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