Polysorb CL-516Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10884521040878), received between Jun 12, 2024 and Jul 7, 2024 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Break” (14 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 16, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN ORTHOPEDIC PROCEDURE, THE NEEDLES OF THE SEVEN SUTURES BROKE AND FELL INTO THE CAVITY. THE SURGEON WAS ABLE TO RETRIEVE THE NEEDLES. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19686867 ↗
• MalfunctionJul 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN ORTHOPEDIC PROCEDURE, THE NEEDLES OF THE SEVEN SUTURES BROKE AND FELL INTO THE CAVITY. THE SURGEON WAS ABLE TO RETRIEVE THE NEEDLES. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19686866 ↗
• MalfunctionJul 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN ORTHOPEDIC PROCEDURE, THE NEEDLES OF THE SEVEN SUTURES BROKE AND FELL INTO THE CAVITY. THE SURGEON WAS ABLE TO RETRIEVE THE NEEDLES. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19686864 ↗
• MalfunctionJul 7, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN ORTHOPEDIC PROCEDURE, THE NEEDLES OF THE SEVEN SUTURED DETACHED FROM THE THREAD AND FELL INTO THE CAVITY. THE SURGEON WAS ABLE TO RETRIEVE THE NEEDLES. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19686857 ↗
• MalfunctionJul 3, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN ORTHOPEDIC PROCEDURE, THE NEEDLES OF THE SEVEN SUTURES BROKE AND FELL INTO THE CAVITY. THE SURGEON WAS ABLE TO RETRIEVE THE NEEDLES. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19665658 ↗
• MalfunctionJul 3, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN ORTHOPEDIC PROCEDURE, THE NEEDLES OF THE SEVEN SUTURED DETACHED FROM THE THREAD AND FELL INTO THE CAVITY. THE SURGEON WAS ABLE TO RETRIEVE THE NEEDLES. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY. THE DEVICES WERE RETURNED WITHOUT ACCOMPANYING INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19665603 ↗
• MalfunctionJul 3, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN ORTHOPEDIC PROCEDURE, THE NEEDLES OF THE SEVEN SUTURED DETACHED FROM THE THREAD AND FELL INTO THE CAVITY. THE SURGEON WAS ABLE TO RETRIEVE THE NEEDLES. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19665544 ↗
• MalfunctionJun 21, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN ORTHOPEDIC SURGERY, THE NEEDLES OF THE THREE SUTURES BROKE OFF. THE THREE NEEDLES FELL INTO THE CAVITY AND WAS REMOVED. A NEW SUTURE FROM THE SAME LOT WAS USED TO RESOLVE THE ISSUE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19589703 ↗
• MalfunctionJun 21, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN ORTHOPEDIC SURGERY, THE NEEDLES OF THE THREE SUTURES BROKE OFF. THE THREE NEEDLES FELL INTO THE CAVITY AND WAS REMOVED. A NEW SUTURE FROM THE SAME LOT WAS USED TO RESOLVE THE ISSUE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19589549 ↗
• MalfunctionJun 21, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN ORTHOPEDIC SURGERY, THE NEEDLES OF THE THREE SUTURES BROKE OFF. THE THREE NEEDLES FELL INTO THE CAVITY AND WAS REMOVED. A NEW SUTURE FROM THE SAME LOT WAS USED TO RESOLVE THE ISSUE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19589081 ↗
• MalfunctionJun 12, 2024Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, IN AN ORTHOPEDIC HIP HEMIARTHROPLASTY PROCEDURE, WHILE EMPLOYING A NORMAL SUTURING TECHNIQUE FOR THE FIRST LAYER DURING CLOSING, THE NEEDLE OF THREE (3) SUTURES BROKE. THE FIRST SUTURE FELL INTO THE CAVITY AND WAS REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE.  THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19524802 ↗
• MalfunctionJun 12, 2024Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, IN AN ORTHOPEDIC HIP HEMIARTHROPLASTY PROCEDURE, WHILE EMPLOYING A NORMAL SUTURING TECHNIQUE FOR THE FIRST LAYER DURING CLOSING, THE NEEDLE OF THREE (3) SUTURES BROKE. THE FIRST SUTURE FELL INTO THE CAVITY AND WAS REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19524774 ↗
• MalfunctionJun 12, 2024Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, IN AN ORTHOPEDIC HIP HEMIARTHROPLASTY PROCEDURE, WHILE EMPLOYING A NORMAL SUTURING TECHNIQUE FOR THE FIRST LAYER DURING CLOSING, THE NEEDLE OF THREE (3) SUTURES BROKE. THE FIRST SUTURE FELL INTO THE CAVITY AND WAS REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE.  THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19524758 ↗
• MalfunctionJun 12, 2024Break; Break

  ACCORDING TO THE REPORTER, IN AN ORTHOPEDIC HIP HEMIARTHROPLASTY PROCEDURE, WHILE EMPLOYING A NORMAL SUTURING TECHNIQUE FOR THE FIRST LAYER DURING CLOSING, THE NEEDLE OF THREE (3) SUTURES BROKE. THE FIRST SUTURE FELL INTO THE CAVITY AND WAS REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19524722 ↗
• MalfunctionJun 12, 2024Break; Break

  ACCORDING TO THE REPORTER, IN AN ORTHOPEDIC HIP HEMIARTHROPLASTY PROCEDURE, WHILE EMPLOYING A NORMAL SUTURING TECHNIQUE FOR THE FIRST LAYER DURING CLOSING, THE NEEDLE OF THREE (3) SUTURES BROKE. THE FIRST SUTURE FELL INTO THE CAVITY AND WAS REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19524688 ↗
• MalfunctionJun 12, 2024Break; Break

  ACCORDING TO THE REPORTER, IN AN ORTHOPEDIC HIP HEMIARTHROPLASTY PROCEDURE, WHILE EMPLOYING A NORMAL SUTURING TECHNIQUE FOR THE FIRST LAYER DURING CLOSING, THE NEEDLE OF SEVEN (7) SUTURES BROKE. THE FIRST SUTURE FELL INTO THE CAVITY AND WAS REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE.  THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19524613 ↗
• MalfunctionJun 12, 2024Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, IN AN ORTHOPEDIC HIP HEMIARTHROPLASTY PROCEDURE, WHILE EMPLOYING A NORMAL SUTURING TECHNIQUE FOR THE FIRST LAYER DURING CLOSING, THE NEEDLE OF SEVEN (7) SUTURES BROKE. THE FIRST SUTURE FELL INTO THE CAVITY AND WAS REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE.  THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19522372 ↗

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