Polysorb CL-845Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10884521042414), received between Oct 5, 2018 and Nov 25, 2025 — classified as 27 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (25 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 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SUTURE NEEDLE DETACHED FROM THE STRAND WHILE BEING REMOVED FROM THE RETAINER AND PREPARED PRIOR TO PATIENT INCISION. 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 23642457 ↗
• MalfunctionNov 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN TOTAL KNEE REPLACEMENT, DURING SUTURING THE TISSUE, THE NEEDLE DETACHED FROM THE TWO SUTURES AND ANOTHER SIX SUTURES FROM A DIFFERENT BATCH. THE NEEDLES DID NOT FALL INTO THE PATIENT¿S CAVITY. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23487707 ↗
• MalfunctionNov 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN TOTAL KNEE REPLACEMENT, DURING SUTURING THE TISSUE, THE NEEDLE DETACHED FROM THE TWO SUTURES AND ANOTHER SIX SUTURES FROM A DIFFERENT BATCH. THE NEEDLES DID NOT FALL INTO THE PATIENT¿S CAVITY. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23487610 ↗
• MalfunctionNov 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN TOTAL KNEE REPLACEMENT, DURING SUTURING THE TISSUE, THE NEEDLE DETACHED FROM THE TWO SUTURES AND ANOTHER SIX SUTURES FROM A DIFFERENT BATCH. THE NEEDLES DID NOT FALL INTO THE PATIENT¿S CAVITY. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23487478 ↗
• MalfunctionNov 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN TOTAL KNEE REPLACEMENT, DURING SUTURING THE TISSUE, THE NEEDLE DETACHED FROM THE TWO SUTURES AND ANOTHER SIX SUTURES FROM A DIFFERENT BATCH. THE NEEDLES DID NOT FALL INTO THE PATIENT¿S CAVITY. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23487450 ↗
• MalfunctionNov 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN TOTAL KNEE REPLACEMENT, DURING SUTURING THE TISSUE, THE NEEDLE DETACHED FROM THE TWO SUTURES AND ANOTHER SIX SUTURES FROM A DIFFERENT BATCH. THE NEEDLES DID NOT FALL INTO THE PATIENT¿S CAVITY. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23487411 ↗
• MalfunctionNov 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN TOTAL KNEE REPLACEMENT, DURING SUTURING THE TISSUE, THE NEEDLE DETACHED FROM THE TWO SUTURES AND ANOTHER SIX SUTURES FROM A DIFFERENT BATCH. THE NEEDLES DID NOT FALL INTO THE PATIENT¿S CAVITY. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23487327 ↗
• MalfunctionNov 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN TOTAL KNEE REPLACEMENT, DURING SUTURING THE TISSUE, THE NEEDLE DETACHED FROM THE TWO SUTURES AND ANOTHER SIX SUTURES FROM A DIFFERENT BATCH. THE NEEDLES DID NOT FALL INTO THE PATIENT¿S CAVITY. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23487221 ↗
• MalfunctionNov 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN TOTAL KNEE REPLACEMENT, DURING SUTURING THE TISSUE, THE NEEDLE DETACHED FROM THE TWO SUTURES AND ANOTHER SIX SUTURES FROM A DIFFERENT BATCH. THE NEEDLES DID NOT FALL INTO THE PATIENT¿S CAVITY. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23487115 ↗
• MalfunctionSep 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE KEPT BREAKING OFF FROM THE THREAD. THE SAME ISSUE OCCURRED FROM THE SAME SUTURE FROM A DIFFERENT BOX. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23043167 ↗
• MalfunctionSep 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE KEPT BREAKING OFF FROM THE THREAD. THE SAME ISSUE OCCURRED FROM THE SAME SUTURE FROM A DIFFERENT BOX. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23042943 ↗
• MalfunctionSep 9, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING TOTAL JOINT SURGERY, THE SUTURE EXPERIENCED NEEDLE DETACHMENT. A NEW SUTURE WAS USED TO RESOLVED THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23001098 ↗
• MalfunctionSep 9, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING TOTAL HIP SURGERY, THE SUTURE EXPERIENCED NEEDLE DETACHMENT. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23001071 ↗
• MalfunctionSep 9, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING TOTAL HIP AND TOTAL KNEE SURGERY; THE NEEDLE CAME OFF THE SUTURE DURING THE FIRST STITCH WHILE SUTURING AFTER PATIENT INCISION. IT WAS NOTED THAT THE SURGICAL TIME WAS EXTENDED. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23000721 ↗
• MalfunctionJul 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SURGICAL ROBOTIC ANTERIOR TOTAL HIP REPLACEMENT, THE SUTURE NEEDLE DETACHED, DESCRIBED AS THE NEEDLE POPPING OFF IN THIRTEEN PACKETS FROM THE SAME BOX. ALL THIRTEEN PACKETS WERE USED AND EACH EXPERIENCED THE SAME ISSUE. THE PROCEDURE WAS EXTENDED, BUT THE EXACT DURATION WAS NOT SPECIFIED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22479561 ↗
• MalfunctionJul 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SURGICAL ROBOTIC ANTERIOR TOTAL HIP REPLACEMENT, THE SUTURE NEEDLE DETACHED, DESCRIBED AS THE NEEDLE POPPING OFF IN THIRTEEN PACKETS FROM THE SAME BOX. ALL THIRTEEN PACKETS WERE USED AND EACH EXPERIENCED THE SAME ISSUE. THE PROCEDURE WAS EXTENDED, BUT THE EXACT DURATION WAS NOT SPECIFIED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22479458 ↗
• MalfunctionJul 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SURGICAL ROBOTIC ANTERIOR TOTAL HIP REPLACEMENT, THE SUTURE NEEDLE DETACHED, DESCRIBED AS THE NEEDLE POPPING OFF IN THIRTEEN PACKETS FROM THE SAME BOX. ALL THIRTEEN PACKETS WERE USED AND EACH EXPERIENCED THE SAME ISSUE. THE PROCEDURE WAS EXTENDED, BUT THE EXACT DURATION WAS NOT SPECIFIED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22479414 ↗
• MalfunctionJul 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SURGICAL ROBOTIC ANTERIOR TOTAL HIP REPLACEMENT, THE SUTURE NEEDLE DETACHED, DESCRIBED AS THE NEEDLE POPPING OFF IN THIRTEEN PACKETS FROM THE SAME BOX. ALL THIRTEEN PACKETS WERE USED AND EACH EXPERIENCED THE SAME ISSUE. THE PROCEDURE WAS EXTENDED, BUT THE EXACT DURATION WAS NOT SPECIFIED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22479373 ↗
• MalfunctionJul 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SURGICAL ROBOTIC ANTERIOR TOTAL HIP REPLACEMENT, THE SUTURE NEEDLE DETACHED, DESCRIBED AS THE NEEDLE POPPING OFF IN THIRTEEN PACKETS FROM THE SAME BOX. ALL THIRTEEN PACKETS WERE USED AND EACH EXPERIENCED THE SAME ISSUE. THE PROCEDURE WAS EXTENDED, BUT THE EXACT DURATION WAS NOT SPECIFIED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22479309 ↗
• MalfunctionJul 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SURGICAL ROBOTIC ANTERIOR TOTAL HIP REPLACEMENT, THE SUTURE NEEDLE DETACHED, DESCRIBED AS THE NEEDLE POPPING OFF IN THIRTEEN PACKETS FROM THE SAME BOX. ALL THIRTEEN PACKETS WERE USED AND EACH EXPERIENCED THE SAME ISSUE. THE PROCEDURE WAS EXTENDED, BUT THE EXACT DURATION WAS NOT SPECIFIED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22479235 ↗
• MalfunctionJul 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SURGICAL ROBOTIC ANTERIOR TOTAL HIP REPLACEMENT, THE SUTURE NEEDLE DETACHED, DESCRIBED AS THE NEEDLE POPPING OFF IN THIRTEEN PACKETS FROM THE SAME BOX. ALL THIRTEEN PACKETS WERE USED AND EACH EXPERIENCED THE SAME ISSUE. THE PROCEDURE WAS EXTENDED, BUT THE EXACT DURATION WAS NOT SPECIFIED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22479209 ↗
• MalfunctionJul 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SURGICAL ROBOTIC ANTERIOR TOTAL HIP REPLACEMENT, THE SUTURE NEEDLE DETACHED, DESCRIBED AS THE NEEDLE POPPING OFF IN THIRTEEN PACKETS FROM THE SAME BOX. ALL THIRTEEN PACKETS WERE USED AND EACH EXPERIENCED THE SAME ISSUE. THE PROCEDURE WAS EXTENDED, BUT THE EXACT DURATION WAS NOT SPECIFIED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22479153 ↗
• MalfunctionJul 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SURGICAL ROBOTIC ANTERIOR TOTAL HIP REPLACEMENT, THE SUTURE NEEDLE DETACHED, DESCRIBED AS THE NEEDLE POPPING OFF IN THIRTEEN PACKETS FROM THE SAME BOX. ALL THIRTEEN PACKETS WERE USED AND EACH EXPERIENCED THE SAME ISSUE. THE PROCEDURE WAS EXTENDED, BUT THE EXACT DURATION WAS NOT SPECIFIED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22479047 ↗
• MalfunctionJul 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SURGICAL ROBOTIC ANTERIOR TOTAL HIP REPLACEMENT, THE SUTURE NEEDLE DETACHED, DESCRIBED AS THE NEEDLE POPPING OFF IN THIRTEEN PACKETS FROM THE SAME BOX. ALL THIRTEEN PACKETS WERE USED AND EACH EXPERIENCED THE SAME ISSUE. THE PROCEDURE WAS EXTENDED, BUT THE EXACT DURATION WAS NOT SPECIFIED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22478993 ↗
• MalfunctionJul 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SURGICAL ROBOTIC ANTERIOR TOTAL HIP REPLACEMENT, THE SUTURE NEEDLE DETACHED, DESCRIBED AS THE NEEDLE POPPING OFF IN THIRTEEN PACKETS FROM THE SAME BOX. ALL THIRTEEN PACKETS WERE USED AND EACH EXPERIENCED THE SAME ISSUE. THE PROCEDURE WAS EXTENDED, BUT THE EXACT DURATION WAS NOT SPECIFIED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22475428 ↗

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