Polysorb CL-843Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10884521042391), received between Oct 15, 2019 and Dec 15, 2025 — classified as 10 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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 18 most recent of 18 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

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE NEEDLE POPPED OFF WHILE SUTURING. A SECOND SET OF THE SAME SUTURE TYPE WAS ATTEMPTED AND AGAIN POPPED OFF THE NEEDLE WITH MINIMAL PRESSURE. A DIFFERENT TYPE OF SUTURE WAS UTILIZED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23800383 ↗
• MalfunctionDec 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE NEEDLE POPPED OFF WHILE SUTURING. A SECOND SET OF THE SAME SUTURE TYPE WAS ATTEMPTED AND AGAIN POPPED OFF THE NEEDLE WITH MINIMAL PRESSURE. A DIFFERENT TYPE OF SUTURE WAS UTILIZED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23800358 ↗
• MalfunctionDec 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A CESAREAN SECTION, THE SUTURE BROKE OFF THE NEEDLE DURING SUTURING. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23771163 ↗
• MalfunctionNov 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN OPEN ORTHOPEDIC PROCEDURE, THE NEEDLES ON BOTH SUTURES DETACHED FROM THE SUTURE STRANDS WHILE SUTURING. THE NEEDLES DID NOT FALL INTO THE PATIENT CAVITY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23566431 ↗
• MalfunctionSep 19, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, AFTER A TOTAL KNEE ARTHROPLASTY (TKA) PROCEDURE, THE TWO SUTURES USED WERE NOT ABSORBED.

  Patient problems: Insufficient Information

  MAUDE report 20258771 ↗
• MalfunctionSep 19, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, AFTER A TOTAL KNEE ARTHROPLASTY (TKA) PROCEDURE, THE THREE SUTURES USED WERE NOT ABSORBED. THERE WAS A WOUND DEHISCENCE.

  Patient problems: Wound Dehiscence

  MAUDE report 20258097 ↗
• MalfunctionDec 8, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVE TO A LEFT TOTAL KNEE REPLACEMENT, THE NEEDLE DETACHED FROM THREE SUTURES WHEN PULLED OUT IN THE PACKAGE. THE SURGEON OPENED A FOURTH ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12965163 ↗
• MalfunctionOct 21, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN PLASTIC SURGERY BODY CONTOURING, THE THREAD BROKE. ANOTHER STRAND WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 12674282 ↗
• InjuryJan 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, A MONTH FOLLOWING AN OPEN HIP REPLACEMENT ARTHROPLASTY, IT WAS STATED THAT ON THE 2ND OF MAY, PATIENT WAS PRESENTED WITH DRAINING HEMATOMA. A REVISION OF RIGHT HIP WITH IRRIGATION DEBRIDEMENT BALL AND LINER EXCHANGE PERFORMED TO CORRECT THE ISSUE.

  Patient problems: Hematoma; No Code Available

  MAUDE report 9548089 ↗
• InjuryJan 3, 2020Mechanical Problem; Unraveled Material; Mechanical Problem; Unraveled Material

  ACCORDING TO THE REPORTER, POST-OPERATIVE OF A KNEE REPLACEMENT ARTHROPLASTY, INCISION AND DRAINAGE OF THE WOUND WAS PERFORMED DUE TO PERSISTENT SUTURE SPITTING AND SUPERFICIAL WOUND DEHISCENCE.

  Patient problems: No Code Available; Wound Dehiscence

  MAUDE report 9547916 ↗
• InjuryJan 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPEN INTRAMEDULLARY NAILING OF TIBIA, THE PATIENT EXPERIENCED CELLULITIS.

  Patient problems: Cellulitis

  MAUDE report 9546504 ↗
• InjuryNov 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT PRESENTED WOUND COMPLICATION FOLLOWING A TOTAL KNEE REPLACEMENT.

  Patient problems: No Code Available

  MAUDE report 9335188 ↗
• InjuryNov 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, FOLLOWING INCISION CLOSURE ON AN OPEN TOTAL KNEE REPLACEMENT, THE PATIENT PRESENTED WITH WOUND COMPLICATIONS.

  Patient problems: Impaired Healing; Post Operative Wound Infection

  MAUDE report 9329177 ↗
• InjuryNov 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST OPERATIVELY, ON A TOTAL KNEE PROCEDURE INCISION CLOSURE, THE CASE WAS PERFORMED WITHOUT INCIDENT. THE PATIENT WAS PRESENTED WITH WOUND COMPLICATION. THE TWO SUTURES WERE REMOVED FROM THE PATIENT.

  Patient problems: No Code Available; Post Operative Wound Infection

  MAUDE report 9269427 ↗
• InjuryNov 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, AFTER OPEN TOTAL KNEE PROCEDURE, UPON INCISION CLOSURE USING BOTH SUTURE, THE CASE WAS PERFORMED WITHOUT INCIDENT. TWO MONTHS LATER, PATIENT PRESENTED WITH WOUND COMPLICATION. THE PATIENT WAS TREATED WITH ANTIBIOTICS.

  Patient problems: Injury; Post Operative Wound Infection

  MAUDE report 9266759 ↗
• InjuryOct 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE CASE WAS PERFORMED WITHOUT AN INCIDENT, HOWEVER, EIGHT MONTHS AFTER THE OPEN TOTAL KNEE REPLACEMENT, THE PATIENT WAS SEEN AND TREATED FOR A SUTURE GRANULOMA.

  Patient problems: Granuloma; No Code Available

  MAUDE report 9209535 ↗
• InjuryOct 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVELY A TOTAL HIP REPLACEMENT PROCEDURE, 5 WEEKS AFTER THE PROCEDURE THE PATIENT PRESENTED CELLULITIS. AFTER 10 DAYS THE PATIENT WAS CONFIRMED TO HAVE MRSA (METHICILLIN - RESISTANT STAPHYLOCOCCUS AUREUS).

  Patient problems: Cellulitis; Post Operative Wound Infection

  MAUDE report 9198313 ↗
• InjuryOct 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVE A TOTAL KNEE REPLACEMENT PROCEDURE LAST JULY, AT THE INCISION CLOSURE AREA, PATIENT PRESENTED A WOULD COMPLICATIONS. PREVIOUSLY, CASE WAS COMPLETED WITHOUT ANY INCIDENT.

  Patient problems: No Code Available; Wound Dehiscence

  MAUDE report 9192040 ↗

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