Polysorb UL-878Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 10884521049635), received between Aug 31, 2017 and Apr 7, 2026 — classified as 5 injuries, 36 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (19 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 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 7, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC MYOMECTOMY, WHILE SUTURING THE TROCAR ORIFICE, UPON OPENING THE PACKAGING, THE NEEDLE AND THREAD WERE DETACHED. ANOTHER PACK OF SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24796793 ↗
• MalfunctionFeb 5, 2026Break

  IT WAS REPORTED THAT DURING A PROCEDURE, UPON OPENING THE PACKAGING, BROKEN THREADS WERE FOUND IN SIX PACKS. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. NO CONSEQUENCES OR IMPACT TO THE PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24272287 ↗
• MalfunctionFeb 5, 2026Break

  IT WAS REPORTED THAT DURING A PROCEDURE, UPON OPENING THE PACKAGING, BROKEN THREADS WERE FOUND IN SIX PACKS. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. NO CONSEQUENCES OR IMPACT TO THE PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24272248 ↗
• MalfunctionFeb 5, 2026Break

  IT WAS REPORTED THAT DURING A PROCEDURE, UPON OPENING THE PACKAGING, BROKEN THREADS WERE FOUND IN SIX PACKS. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. NO CONSEQUENCES OR IMPACT TO THE PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24272053 ↗
• MalfunctionFeb 5, 2026Break

  IT WAS REPORTED THAT DURING A PROCEDURE, UPON OPENING THE PACKAGING, BROKEN THREADS WERE FOUND IN SIX PACKS. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. NO CONSEQUENCES OR IMPACT TO THE PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24271995 ↗
• MalfunctionFeb 5, 2026Break

  IT WAS REPORTED THAT DURING A PROCEDURE, UPON OPENING THE PACKAGING, BROKEN THREADS WERE FOUND IN SIX PACKS. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. NO CONSEQUENCES OR IMPACT TO THE PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24271887 ↗
• MalfunctionFeb 5, 2026Break

  IT WAS REPORTED THAT DURING A PROCEDURE, UPON OPENING THE PACKAGING, BROKEN THREADS WERE FOUND IN SIX PACKS. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. NO CONSEQUENCES OR IMPACT TO THE PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24271681 ↗
• InjuryAug 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT UNDERWENT RIGHT ACHILLES TENDON RUPTURE REPAIR SURGERY, AFTER SUCCESSFUL ANESTHESIA, A 7 CM LONGITUDINAL INCISION WAS MADE ON THE INSIDE OF THE ACHILLES TENDON RUPTURE, AND THE SKIN, SUBCUTANEOUS TISSUE, AND DEEP FASCIA WERE CUT LAYER BY LAYER UNTIL THE ACHILLES TENDON STUMP WAS EXPOSED. THE ACHILLES TENDON WAS TORN IN A HORSETAIL SHAPE ABOUT 4 CM ABOVE THE CALCANEAL TUBEROSITY, AND THE PLANTAR TENDON WAS NORMAL. THE BLOOD CLOTS WERE CLEANED, THE STUMP WAS COMBED, AND TWO HIGH-STRENGTH SUTURES (SUTURES USED IN CONJUNCTION WITH BONE ANCHORS) WERE OVERLAPPED TO SUTURE THE ACHILLES TENDON STUMP, WITH INTERRUPTED SUTURE, AND SEVERAL STITCHES WERE SUTURED THROUGH THE MIDDLE OF THE TENDON. A MEDIUM 3.5X13.2 NON-ABSORBABLE ANCHOR WITH THREAD WAS THEN INSERTED INTO THE CALCANEAL INSERTION POINT, AND THE ACHILLES TENDON WAS STRENGTHENED AND FIXED BY BRAIDING SUTURE PROXIMALLY. CHECKING THAT THE CALCANEAL TUBEROSITY WAS EQUAL TO THE OPPOSITE SIDE, THE TENSION OF THE ACHILLES TENDON WAS RESTORED, THE WOUND WAS RINSED, AND EACH LAYER WAS TIGHTLY SUTURED WITH SYNTHETIC ABSORBABLE SURGICAL SUTURE 2-0, STERILE DRESSING WAS APPLIED WITH PRESSURE BANDAGE, TOUR

  Patient problems: Necrosis; Swelling/ Edema

  MAUDE report 22717326 ↗
• MalfunctionMay 7, 2025Mechanical Problem; Patient-Device Incompatibility; Mechanical Problem; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, 48 DAYS FOLLOWING A PROCEDURE FOR A BROKEN ACHILLES TENDON, IT WAS OBSERVED DURING AN OUTPATIENT REVIEW THAT THE PATIENT HAD POOR WOUND HEALING AND EXUDATION FROM THE SURGICAL INCISION. OUTPATIENT DEBRIDEMENT AND DRESSING CHANGE WERE PERFORMED.

  Patient problems: Impaired Healing

  MAUDE report 21978835 ↗
• MalfunctionApr 4, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ESOPHAGEAL MALIGNANT TUMOR SURGERY, WOUND CLOSURE/SURGICAL INCISION CLOSURE, THE CENTRAL PART OF THE NEEDLE WAS DAMAGED. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21774588 ↗
• MalfunctionDec 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LEFT SIDE HEMICOLECTOMY PROCEDURE INVOLVING THE SUTURE, A NEEDLE DETACHMENT OCCURRED WHILE SUTURING OR PREPARING THE SUTURE AFTER THE PATIENT INCISION. THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THE EVENT DID NOT RESULT IN ANY CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20844895 ↗
• MalfunctionNov 13, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE QUANTITY PER PACKET WAS 36, BUT THERE WERE ONLY 35. THE PRODUCT WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20676147 ↗
• InjuryAug 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT UNDERWENT LEFT PATELLAR TENDON RUPTURE REPAIR PLUS LEFT TIBIAL TUBERCLE FRACTURE OPEN REDUCTION AND INTERNAL FIXATION. ROUTINE DISINFECTION AND DRAPING OF THE LEFT KNEE, EXPELLED BLOOD. THE PERIOSTEUM OF THE MIDDLE AND UPPER PART OF THE LEFT TIBIA AND A SMALL AMOUNT OF THE ANTERIOR TIBIALIS MUSCLE WERE TORN, THE FRACTURE ENDS AND TIBIAL TENDONS WERE CLEANED. A 4.5MM POLYETHER ETHER KETONE SUTURE ANCHOR STAPLE WAS INSERTED RESPECTIVELY AT 1 CM PROXIMAL TO THE EPIPHYSEAL LINE ON BOTH SIDES OF THE TIBIAL TUBERCLE. FOUR STRANDS OF SUTURE WERE PASSED THROUGH THE TENDON-BONE JUNCTION OF THE DISTAL PATELLAR TENDON. THE PROXIMAL TIBIAL BONE FRAGMENT AND THE TIBIAL TUBERCLE BONE FRAGMENT WERE REPOSITIONED, AND TWO HOLLOW SCREW GUIDE PINS WERE USED FOR TEMPORARY FIXATION. THE POSITION OF THE BONE FRAGMENT WAS GOOD UNDER FLUOROSCOPY. TWO 4.5 X50 HOLLOW SCREWS WERE DRILLED AND SCREWED IN. THE WHITE HIGH-STRENGTH LINE OF THE ANCHOR STAPLE WAS KNOTTED AND FIXED, AND THE WHITE-BLUE LINE WAS KNOTTED AS A "DOUBLE PUL LEY", AND A 5.MM POLYETHER ETHER KETONE SUTURE ANCHOR STAPLE WAS INSERTED ON THE INNER AND OUTER SIDES OF THE TIBIA. THE WHITE-BLUE ANCHOR WIRE W

  Patient problems: Inflammation

  MAUDE report 19974671 ↗
• InjuryJun 21, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC TOTAL HYSTERECTOMY PROCEDURE, AT THE TIME OF SUTURING THE END OF THE VAGINAL CUT VIA CONTINUOUS SUTURING TECHNIQUE, THE NEEDLE BROKE. X-RAYS WERE TAKEN THREE TIMES TO CONFIRM IF THERE WAS A NEEDLE REMAINING IN THE BODY. THE SURGEON WAS UNABLE TO RETRIEVE THE BROKEN PIECE. THIS LED TO 30 MINUTES OR MORE EXTENDED SURGICAL TIME. IT WAS NOTED THAT THE SURGEON CONVERTED THE PROCEDURE INTO A SMALL LAPAROTOMY, BUT IT WAS NOT DUE TO A DEVICE PROBLEM.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 19588778 ↗
• MalfunctionMay 14, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, PRIOR TO PATIENT USE FOR SUTURING TISSUE, WHEN THE SURGICAL NURSE PREPARED THE SYNTHETIC ABSORBABLE SURGICAL, IT WAS FOUND THAT THE SUTURE NEEDLE SEPARATED FROM THE SUTURE JUNCTION. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19314258 ↗
• MalfunctionJan 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE SUTURE WAS DISENGAGED FROM THE NEEDLE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18480858 ↗
• MalfunctionSep 5, 2023Component Missing; Component Missing

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ADNEXECTOMY, AT THE TIME OF CLOSING THE WOUND, THE PACKAGE WAS OPENED, BUT THERE WAS NO SUTURE NEEDLE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17684190 ↗
• MalfunctionJun 30, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC APPENDECTOMY TO REMOVE THE APPENDIX, CONTROL THE INFECTION AND PERFORATION AND CAUSED DAMAGE, WHEN THE FIRST STITCH WAS SUTURED, THE NEEDLE AND SUTURE WERE DETACHED. THE SUTURING OPERATION COULD NOT BE COMPLETED AND THE NEEDLE PUNCTURE CAUSED THE SKIN DAMAGE. NEW SUTURES WERE USED TO CONTINUE SUTURING THE WOUND.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17244037 ↗
• MalfunctionApr 21, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVELY, BEFORE TAKING DEVICE OUT IN THE SURGICAL FIELD, THE NURSE TRIED TO TAKE OUT THE NEEDLE FROM THE PACKAGE BUT THE NEEDLE AND THREAD CAME OFF. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16788052 ↗
• MalfunctionMar 9, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC CHOLECYSTECTOMY, WHEN CLOSING THE UMBILICAL WOUND, THE SURGEON TRIED TO SCOOP UP THE NEEDLE BUT THE TIP OF THE NEEDLE DID NOT PENETRATE AND BROKE. THE NEEDLE TIP WAS FOUND IMMEDIATELY. ANOTHER DEVICE 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 16513808 ↗
• MalfunctionFeb 8, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, BEFORE SUTURING, THE NEEDLE WAS CLAMPED WITH A NEEDLE HOLDER AND WHEN TRIED TAKING IT OUT FROM THE PACKAGE, THE NEEDLE AND THE SUTURE DISCONNECTED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16323046 ↗
• MalfunctionJan 23, 2023Component Missing; Component Missing

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE PRODUCT WAS UNPACKED BUT THE CARDBOARD, STAPLE, AND SUTURE WERE NOT IN IT. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16228419 ↗
• MalfunctionNov 29, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, UPON OPENING THE PACKAGE, IT WAS DISCOVERED THAT THE NEEDLE AND SUTURE HAD COME OFF. THE DEVICE WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15880125 ↗
• MalfunctionJul 26, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SURGERY, AFTER OPENING, THE NEEDLE DETACHED FROM THE THREAD. 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 15107969 ↗
• MalfunctionJul 26, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE NEEDLE AND THREAD WERE FOUND TO BE DISENGAGED WHEN THE PRODUCT WAS OPENED. A NEW SUTURE WAS USED WITHOUT AN ISSUE. NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15103988 ↗

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