Polysorb CL-803Recalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 10884521041868), received between Aug 31, 2017 and Apr 15, 2026 — classified as 5 injuries, 49 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (48 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 54 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 15, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT PREOPERATIVELY, WHEN PREPARING THE SUTURE AFTER A PATIENT INCISION, THE NEEDLE DETACHED FROM THE SUTURE. A REPLACEMENT SUTURE FROM THE SAME LOT WAS USED, BUT THE NEEDLE AND SUTURE DETACHED AGAIN. A PRODUCT FROM A DIFFERENT LOT NUMBER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24885136 ↗
• MalfunctionApr 15, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT PREOPERATIVELY, WHEN PREPARING THE SUTURE AFTER A PATIENT INCISION, THE NEEDLE DETACHED FROM THE SUTURE. A REPLACEMENT SUTURE FROM THE SAME LOT WAS USED, BUT THE NEEDLE AND SUTURE DETACHED AGAIN. A PRODUCT FROM A DIFFERENT LOT NUMBER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24885041 ↗
• MalfunctionApr 15, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT PREOPERATIVELY, WHEN PREPARING THE SUTURE AFTER A PATIENT INCISION, THE NEEDLE DETACHED FROM THE SUTURE. A REPLACEMENT SUTURE FROM THE SAME LOT WAS USED, BUT THE NEEDLE AND SUTURE DETACHED AGAIN. A PRODUCT FROM A DIFFERENT LOT NUMBER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24884915 ↗
• MalfunctionApr 13, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TOTAL KNEE REPLACEMENT, NEEDLE DETACHMENT OCCURRED ON THE 18 SUTURES WHILE REMOVING THE NEEDLE FROM THE RETAINER. A PRODUCT FROM A DIFFERENT LOT NUMBER WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24866213 ↗
• MalfunctionApr 13, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TOTAL KNEE REPLACEMENT, NEEDLE DETACHMENT OCCURRED ON THE 18 SUTURES WHILE REMOVING THE NEEDLE FROM THE RETAINER. A PRODUCT FROM A DIFFERENT LOT NUMBER WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24866137 ↗
• MalfunctionApr 13, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TOTAL KNEE REPLACEMENT, NEEDLE DETACHMENT OCCURRED ON THE 18 SUTURES WHILE REMOVING THE NEEDLE FROM THE RETAINER. A PRODUCT FROM A DIFFERENT LOT NUMBER WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24866136 ↗
• MalfunctionApr 13, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TOTAL KNEE REPLACEMENT, NEEDLE DETACHMENT OCCURRED ON THE 18 SUTURES WHILE REMOVING THE NEEDLE FROM THE RETAINER. A PRODUCT FROM A DIFFERENT LOT NUMBER WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24865965 ↗
• MalfunctionApr 13, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TOTAL KNEE REPLACEMENT, NEEDLE DETACHMENT OCCURRED ON THE 18 SUTURES WHILE REMOVING THE NEEDLE FROM THE RETAINER. A PRODUCT FROM A DIFFERENT LOT NUMBER WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24865934 ↗
• MalfunctionApr 13, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TOTAL KNEE REPLACEMENT, NEEDLE DETACHMENT OCCURRED ON THE 18 SUTURES WHILE REMOVING THE NEEDLE FROM THE RETAINER. A PRODUCT FROM A DIFFERENT LOT NUMBER WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24865922 ↗
• MalfunctionApr 13, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TOTAL KNEE REPLACEMENT, NEEDLE DETACHMENT OCCURRED ON THE 18 SUTURES WHILE REMOVING THE NEEDLE FROM THE RETAINER. A PRODUCT FROM A DIFFERENT LOT NUMBER WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24865907 ↗
• MalfunctionApr 13, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TOTAL KNEE REPLACEMENT, NEEDLE DETACHMENT OCCURRED ON THE 18 SUTURES WHILE REMOVING THE NEEDLE FROM THE RETAINER. A PRODUCT FROM A DIFFERENT LOT NUMBER WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24865846 ↗
• MalfunctionApr 13, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TOTAL KNEE REPLACEMENT, NEEDLE DETACHMENT OCCURRED ON THE 18 SUTURES WHILE REMOVING THE NEEDLE FROM THE RETAINER. A PRODUCT FROM A DIFFERENT LOT NUMBER WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24865845 ↗
• MalfunctionApr 13, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TOTAL KNEE REPLACEMENT, NEEDLE DETACHMENT OCCURRED ON THE 18 SUTURES WHILE REMOVING THE NEEDLE FROM THE RETAINER. A PRODUCT FROM A DIFFERENT LOT NUMBER WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24865779 ↗
• MalfunctionApr 13, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TOTAL KNEE REPLACEMENT, NEEDLE DETACHMENT OCCURRED ON THE 18 SUTURES WHILE REMOVING THE NEEDLE FROM THE RETAINER. A PRODUCT FROM A DIFFERENT LOT NUMBER WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24865705 ↗
• MalfunctionApr 13, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TOTAL KNEE REPLACEMENT, NEEDLE DETACHMENT OCCURRED ON THE 18 SUTURES WHILE REMOVING THE NEEDLE FROM THE RETAINER. A PRODUCT FROM A DIFFERENT LOT NUMBER WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24865699 ↗
• MalfunctionApr 13, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TOTAL KNEE REPLACEMENT, NEEDLE DETACHMENT OCCURRED ON THE 18 SUTURES WHILE REMOVING THE NEEDLE FROM THE RETAINER. A PRODUCT FROM A DIFFERENT LOT NUMBER WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24865694 ↗
• MalfunctionApr 13, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TOTAL KNEE REPLACEMENT, NEEDLE DETACHMENT OCCURRED ON THE 18 SUTURES WHILE REMOVING THE NEEDLE FROM THE RETAINER. A PRODUCT FROM A DIFFERENT LOT NUMBER WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24865682 ↗
• MalfunctionApr 13, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TOTAL KNEE REPLACEMENT, NEEDLE DETACHMENT OCCURRED ON THE 18 SUTURES WHILE REMOVING THE NEEDLE FROM THE RETAINER. A PRODUCT FROM A DIFFERENT LOT NUMBER WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24865655 ↗
• MalfunctionApr 13, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TOTAL KNEE REPLACEMENT, NEEDLE DETACHMENT OCCURRED ON THE 18 SUTURES WHILE REMOVING THE NEEDLE FROM THE RETAINER. A PRODUCT FROM A DIFFERENT LOT NUMBER WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24865571 ↗
• MalfunctionApr 13, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TOTAL KNEE REPLACEMENT, NEEDLE DETACHMENT OCCURRED ON THE 18 SUTURES WHILE REMOVING THE NEEDLE FROM THE RETAINER. A PRODUCT FROM A DIFFERENT LOT NUMBER WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24865514 ↗
• MalfunctionApr 13, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TOTAL KNEE REPLACEMENT, NEEDLE DETACHMENT OCCURRED ON THE 18 SUTURES WHILE REMOVING THE NEEDLE FROM THE RETAINER. A PRODUCT FROM A DIFFERENT LOT NUMBER WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24865443 ↗
• MalfunctionMar 23, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT PRE-OPERATIVELY, WHILE PREPARING THE SUTURE AFTER PATIENT INCISION, THE NEEDLE DETACHED FROM THE SUTURE. FOUR SUTURES WERE USED AND HAD THE SAME ISSUE. THE ISSUE WAS RESOLVED BY USING A DIFFERENT LOT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24669358 ↗
• MalfunctionMar 23, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT PRE-OPERATIVELY, WHILE PREPARING THE SUTURE AFTER PATIENT INCISION, THE NEEDLE DETACHED FROM THE SUTURE. FOUR SUTURES WERE USED AND HAD THE SAME ISSUE. THE ISSUE WAS RESOLVED BY USING A DIFFERENT LOT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24669231 ↗
• MalfunctionJan 28, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE TOTAL ABDOMINAL HYSTERECTOMY, THREE NEEDLES DETACHED FROM THE SUTURE WHILE SUTURING. A SUTURE FROM OTHER MANUFACTURER WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24206190 ↗
• MalfunctionJan 28, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE TOTAL ABDOMINAL HYSTERECTOMY, THREE NEEDLES DETACHED FROM THE SUTURE WHILE SUTURING. A SUTURE FROM OTHER MANUFACTURER WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24206146 ↗

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