Polysorb SL-5627Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10884521048508), received between Jul 11, 2018 and Dec 15, 2025 — classified as 9 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (8 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. 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A MINOR PROCEDURE, THE NEEDLE DETACHED FROM THE SUTURE WHILE SUTURING. THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY, AND AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23809693 ↗
• MalfunctionMar 3, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, ON A ROBOTIC LAPAROSCOPIC HERNIA REPAIR, 1.5 HOURS INTO THE PROCEDURE, DURING THE CLOSURE OF ABDOMINAL TISSUE, THE SUTURE POPPED OFF AT THE BASE OF THE NEEDLE IMMEDIATELY UPON PASSING THROUGH TISSUE. ANOTHER SUTURE FROM THE SAME LOT WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16482144 ↗
• MalfunctionJul 26, 2022Break; Detachment of Device or Device Component; Material Twisted/Bent; Break; Detachment of Device or Device Component; Material Twisted/Bent

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SURGEON HAD ISSUES WITH THE DEVICE. 90% OF THE TIME, THE SUTURE COMES OFF THE SWEDGE OR A NEEDLE BENT OR BROKEN. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15107915 ↗
• InjuryMar 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, 3 WEEKS FOLLOWING A PROCEDURE, THE PATIENT EXPERIENCED DEHISCENCE.

  Patient problems: Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 13633815 ↗
• InjuryMar 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, 3 WEEKS FOLLOWING A PROCEDURE, THE PATIENT EXPERIENCED DEHISCENCE.

  Patient problems: Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 13633740 ↗
• InjuryMar 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, 3 WEEKS FOLLOWING A PROCEDURE, THE PATIENT EXPERIENCED DEHISCENCE.

  Patient problems: Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 13633707 ↗
• InjuryMar 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, 3 WEEKS FOLLOWING A PROCEDURE, THE PATIENT EXPERIENCED DEHISCENCE.

  Patient problems: Wound Dehiscence

  MAUDE report 13633444 ↗
• MalfunctionJan 21, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A CAESAREAN SECTION, WHEN CLOSING THE INCISION, THE NEEDLE AND THREAD OF 2 SUTURE DEVICES WERE DETACHED. A THIRD DEVICE WAS NEEDED IN ORDER TO CONTINUE THE CLOSURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13312569 ↗
• MalfunctionDec 2, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHILE CLOSING A PACEMAKER POCKET, THE SURGEON PUSHED THE SUTURE THROUGH THE SKIN, THE TIP OF THE NEEDLE WAS GRABBED TO BRING THE SUTURE THROUGH, BUT THE SUTURE DETACHED FROM THE NEEDLE. ANOTHER SUTURE WAS OPENED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12917348 ↗
• MalfunctionAug 4, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, ON A C-SECTION, DURING CLOSURE, THE NEEDLE SNAPPED OFF. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12278202 ↗
• InjuryJun 29, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC LOW ANTERIOR RESECTION WITH COLORECTAL ANASTOMOSIS, THE TIP BROKE OFF IN THE ABDOMEN WHEN CLOSING. THE NEEDLE PIECE THAT BROKE OFF WAS NOT RECOVERED. X-RAY WAS BROUGHT IN BUT UNABLE TO DETECT IT. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE.

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

  MAUDE report 12086574 ↗
• MalfunctionMar 22, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING FINAL CLOSURE OF THE SKIN USING A FLAT KNOT TECHNIQUE IN A LAPAROSCOPIC ROBOTIC HERNIA REPAIR, THE NEEDLE BROKE. THE SUTURE BROKE AFTER THE SECOND PASS THROUGH TISSUE. THE STAFF THREW THE BROKEN SUTURE AWAY AND OPENED ANOTHER PACKAGE FROM ANOTHER LOT NUMBER OF THE SAME SUTURE. THAT SUTURE FRAYED AFTER A COUPLE PASSES AND ALSO BROKE, BUT THE PHYSICIAN WAS ABLE TO FINISH THE CLOSURE WITH THE REMAINING SUTURE ON THE BROKEN STRAND. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8446520 ↗
• MalfunctionMar 22, 2019Break; Material Frayed; Break; Material Frayed

  ACCORDING TO THE REPORTER, DURING FINAL CLOSURE OF THE SKIN USING A FLAT KNOT TECHNIQUE IN A LAPAROSCOPIC ROBOTIC HERNIA REPAIR, THE THREAD BROKE. THE SUTURE BROKE AFTER THE SECOND PASS THROUGH TISSUE. THE STAFF THREW THE BROKEN SUTURE AWAY AND OPENED ANOTHER PACKAGE FROM ANOTHER LOT NUMBER OF THE SAME SUTURE. THAT SUTURE FRAYED AFTER A COUPLE PASSES AND ALSO BROKE, BUT THE PHYSICIAN WAS ABLE TO FINISH THE CLOSURE WITH THE REMAINING SUTURE ON THE BROKEN STRAND. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8446519 ↗
• InjuryJan 3, 2019Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, 5-6 WEEKS POST OPERATIVE FROM CLOSING THE SUBCUTICULAR SKIN ON AN OPEN PROCEDURE, THE PATIENT PRESENTED WITH REDNESS OF THE INCISION ON THE FOOT AND WAS COMPLAINING OF PAIN. THEY WAITED FOR THE PATIENT TO BEGIN SPITTING SUTURE SO IT CAN BE REMOVED.

  Patient problems: No Code Available; Pain

  MAUDE report 8212334 ↗
• MalfunctionDec 2, 2018Break; Break

  ACCORDING TO THE REPORTER, WHILE DOING A RUNNING SUTURE DURING ACHILLES TENDON REPAIR, THE THREAD BROKE. THEY OPENED A NEW SUTURE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8123168 ↗
• InjuryNov 28, 2018Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, PATIENT CAME BACK TO OFFICE 4 WEEKS POST BUNIONECTOMY COMPLAINING OF REDNESS OF INCISION. SURGEON NOTED REACTION TO SUTURE. SUTURE WAS REMOVED FROM PATIENT IN THE OFFICE SETTING.

  Patient problems: Reaction

  MAUDE report 8110251 ↗
• InjuryNov 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, THE PATIENT RETURNED 5 WEEKS AFTER AN OPEN BUNIONECTOMY WITH REDNESS AT THE INCISION SITE. THE SURGEON REMOVED THE SUBCUTICULAR STITCH FROM THE INCISION TO COMPLETE THE CASE.

  Patient problems: Foreign Body In Patient; No Code Available; Reaction

  MAUDE report 8050845 ↗
• MalfunctionOct 23, 2018Break; Break

  ACCORDING TO THE REPORTER, WHILE CLOSING THE SKIN DURING AN EXCISION OF BACK LIPOMA, THE SURGEON WAS TYING A KNOT AND THE ENTIRE SUTURE SNAPPED ON THE 5TH KNOT THROW. THEY USED THE SAME SUTURE TO CONTINUE CLOSURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7995270 ↗
• InjuryOct 12, 2018Mechanical Problem; Mechanical Problem

  ACCORDING TO THE REPORTER, THE PATIENT HAD SUTURE ABSCESS FOUR WEEKS FOLLOWING A SUBCUTICULAR SKIN CLOSURE. THE SUTURE WAS SPITTING AT THE KNOT. THE SUTURE WAS REMOVED. IT WAS STATED THAT THE PATIENT WAS FINE.

  Patient problems: Abscess

  MAUDE report 7960777 ↗
• MalfunctionJul 11, 2018Break; Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING CLOSURE OF THE TISSUE IN A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE NEEDLE BROKE AND THE TIP FELL INTO THE PATIENT¿S CAVITY. THEY OPENED ANOTHER SUTURE 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 7677728 ↗

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