Biosyn SM-922Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10884521033313), received between Jun 20, 2018 and Sep 22, 2026 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (10 reports).

28 other recalls cover devices cleared under the same FDA submission (K000037); 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Detachment of Device or Device Component

  According to the during the procedure, the suture needle detached from the suture material while in use. To complete the procedure, new packs of suture were opened and used as a replacement. The case was completed successfully. No patient injury was reported.

  Patient problems: Insufficient Information

  MAUDE report 50853862 ↗
• MalfunctionSep 21, 2026Detachment of Device or Device Component

  Patient problems: Insufficient Information

  MAUDE report 50846530 ↗
• MalfunctionJan 29, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING THE VETERINARY PROCEDURE, THE SUTURE BROKE IMMEDIATELY WHEN A KNOT WAS TIED AND TIGHTENED. A NEW PACK OF SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21265062 ↗
• MalfunctionJan 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE FIRST SUTURE NEEDLE FELL OFF WHEN IT WAS OPENED, AND THE SECOND SUTURE BROKE IMMEDIATELY WHEN A KNOT WAS TIED AND TIGHTENED.

  Patient problems: Insufficient Information

  MAUDE report 21264668 ↗
• MalfunctionJan 29, 2025Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING THE VETERINARY PROCEDURE, THE SUTURE NEEDLE FELL OFF WHEN IT WAS OPENED. A NEW PACK OF SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 21264423 ↗
• MalfunctionOct 30, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A OVARIOHYSTERECTOMY, A VET PROCEDURE, THE SWEDGE ON NEEDLE HAS FALLEN OFF ON THREE DIFFERENT PACKS OF SUTURE. ONE FELL OFF DURING SURGERY AND LANDED INSIDE THE SURGICAL SITE. THE BROKEN COMPONENT WAS RETRIEVED BY USING A PAIR OF NEEDLE DRIVERS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20571147 ↗
• MalfunctionOct 30, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OVARIOHYSTERECTOMY, A VET PROCEDURE, THE SWEDGE ON NEEDLE HAS FALLEN OFF ON THREE DIFFERENT PACKS OF SUTURE. ONE FELL OFF DURING SURGERY AND LANDED INSIDE THE SURGICAL SITE. THE BROKEN COMPONENT WAS RETRIEVED BY USING A PAIR OF NEEDLE DRIVERS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20571088 ↗
• MalfunctionOct 30, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OVARIOHYSTERECTOMY, A VET PROCEDURE, THE SWEDGE ON NEEDLE HAS FALLEN OFF ON THREE DIFFERENT PACKS OF SUTURE. ONE FELL OFF DURING SURGERY AND LANDED INSIDE THE SURGICAL SITE. THE BROKEN COMPONENT WAS RETRIEVED BY USING A PAIR OF NEEDLE DRIVERS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20569806 ↗
• MalfunctionJul 25, 2024Component Missing; Component Missing

  ACCORDING TO THE REPORTER, DURING A CANINE SPAY PROCEDURE, BEFORE THE DEVICE WAS USED ON A PATIENT, NO NEEDLE WAS ATTACHED IN THE PACKET. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19833940 ↗
• MalfunctionJan 30, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING SPAY SURGERY BUT BEFORE USING IT ON THE PATIENT, WHEN THE SUTURE PACK WAS OPENED FOR VETERINARY USE, THE SURGEON ATTACHED THE NEEDLE DRIVERS TO THE SUTURE, PULLED IT OUT FROM THE CONTAINER AND THE SUTURE CAME OFF THE NEEDLE. A NEW PACKET OF SUTURE WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18603964 ↗
• MalfunctionDec 21, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A VET OVARIOHYSTERECTOMY OPEN PROCEDURE, THE SUTURE NEEDLE BROKE IN TWO WHILE BEING DRIVEN THROUGH TISSUE DURING THE CLOSURE OF THE ABDOMINAL BODY WALL. THE PIECE OF NEEDLE WAS ABLE TO BE RETRIEVED FROM THE TISSUE WITH FORCEPS, AND THE AREA WAS THOROUGHLY EXAMINED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18376945 ↗
• MalfunctionFeb 22, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, ON TWO DEVICES, THE NEEDLES WERE COMING OFF THE THREAD WITH MINIMUM AMOUNT OF TENSION BEING APPLIED. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED TOGETHER WITH THE NEEDLE HOLDERS TO TRY TO CRIMP THE NEEDLE ONTO THE SUTURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13577466 ↗
• MalfunctionNov 29, 2021Break; Break

  ACCORDING TO THE REPORTER, WHILE USING SIMPLE CONTINUOUS PATTERN IN CLOSING SUBCUTANEOUS LAYER IN A OVARIOHYSTERECTOMY, THE SUTURE KEPT BREAKING WHEN TYING THE KNOTS ON TWO DEVICES. ANOTHER SUTURE WITH A DIFFERENT LOT NUMBER WAS OPENED BUT THE SAME MALFUNCTIONED OCCURRED. TO RESOLVE THE ISSUE, A DIFFERENT TYPE OF SUTURE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12882023 ↗
• MalfunctionJan 18, 2021Break; Break

  ACCORDING TO THE REPORTER, ONE DAY POST OPEN FELINE OVARIOHYSTERECTOMY, PATIENT RETURNED FOR COMPLAINT OF ABNORMAL BEHAVIOR (HUNCHED OVER AND TREMBLING). EXAMINATION REVEALED A LINEA ALBA HERNIA. WHILE SCRUBBING THE SURGICAL SITE TO PREP FOR REPAIR, THE SUBCUTICULAR SUTURE BROKE OPEN. UPON FURTHER EXPLORATION OF THE SURGICAL SITE, THE SUTURE IN THE LINEA ALBA WAS FOUND TO BE BROKEN. AN ADDITIONAL NEW SUTURE USED WITHOUT ISSUE. HOSPITALIZATION WAS EXTENDED TO A DAY. SURGICAL TIME EXTENDED 30 MINUTES OR MORE DUE TO THE PRODUCT PROBLEM.

  Patient problems: Hernia

  MAUDE report 11189609 ↗
• MalfunctionJan 18, 2021Break; Break

  ACCORDING TO THE REPORTER, 3 DAYS AFTER AN OPEN FELINE OVARIOHYSTERECTOMY, THE PATIENT RETURNED FOR COMPLAINT OF A RED, SWOLLEN INCISION THAT WAS WARM TO THE TOUCH. EXAMINATION REVEALED A SWOLLEN AREA OVER THE LINEA ALBA AND BRUISING OF THE ABDOMEN. ABDOMINAL ULTRASOUND REVEALED SOFT TISSUE BELOW THE INCISION, CONSISTENT WITH A LINEA ALBA HERNIA. SURGICAL REPAIR FOUND THE KNOTS OF SUTURE MATERIAL ALONG THE LINEA ALBA WERE INTACT, HOWEVER THE SUTURE WAS BROKEN. TISSUE DAMAGE WAS NOTED. ADDITIONAL NEW SUTURE USED WITHOUT ISSUE.

  Patient problems: Hernia; Swelling/ Edema; Unintended Radiation Exposure; Unspecified Tissue Injury

  MAUDE report 11189111 ↗
• MalfunctionAug 27, 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, THE PATIENT HAD A SUTURE REACTION FOLLOWING A SPAY PROCEDURE. ANOTHER SURGERY WAS DONE AND ANTIBIOTICS WERE MINISTERED. IT WAS ALSO STATED THAT SURGICAL TIME WAS EXTENDED TO 30 MINUTES AND THE EVENT LEAD TO PATIENT¿S EXTENDED HOSPITALIZATION.

  Patient problems: No Code Available; Swelling; Wound Dehiscence

  MAUDE report 8938154 ↗
• MalfunctionAug 27, 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, THE PATIENT HAD A SUTURE REACTION, DEHISCENCE, AND PUSS WELLING FOLLOWING A SPAY PROCEDURE. ANOTHER SURGERY WAS DONE AND ANTIBIOTICS WAS MINISTERED. IT WAS ALSO STATED THAT SURGICAL TIME WAS EXTENDED TO 30 MINUTES AND THE EVENT LEAD TO PATIENTS EXTENDED HOSPITALIZATION.

  Patient problems: No Code Available; Swelling; Wound Dehiscence

  MAUDE report 8938130 ↗
• MalfunctionAug 27, 2019Unraveled Material; Adverse Event Without Identified Device or Use Problem; Unraveled Material; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER POST OPERATIVE A SPAYING PROCEDURE, THE PATIENT WAS RETURNED WITH INFECTIONS AND WOUND DEHISCENCE. THE OPEN WOUND WAS RE-SUTURED AND TREATED WITH ANTIBIOTICS. THERE WAS NO PATIENT HARM.

  Patient problems: No Code Available; Post Operative Wound Infection; Wound Dehiscence

  MAUDE report 8935263 ↗
• MalfunctionAug 27, 2019Unraveled Material; Adverse Event Without Identified Device or Use Problem; Unraveled Material; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER POST OPERATIVE A SPAYING PROCEDURE, THE PATIENT WAS RETURNED WITH INFECTIONS AND WOUND DEHISCENCE. THE OPEN WOUND WAS RE-SUTURED AND TREATED WITH ANTIBIOTICS. THERE WAS NO PATIENT HARM.

  Patient problems: No Code Available; Post Operative Wound Infection; Wound Dehiscence

  MAUDE report 8935194 ↗
• MalfunctionNov 11, 2018Break; Break

  ACCORDING TO THE REPORTER, THE SUTURE WAS APPLIED IN A VETERINARY PROCEDURE TO THE ABDOMINAL MUSCLE USING A CONTINUOUS SUTURING TECHNIQUE. POST-OPERATIVELY, THE MIDDLE OF THE SUTURE LINE BROKE. THE PATIENT HAD TO BE BROUGHT BACK IN TO REDO THE SUTURE LINE.

  Patient problems: No Code Available

  MAUDE report 8058528 ↗
• MalfunctionNov 11, 2018Break; Unraveled Material; Break; Unraveled Material

  ACCORDING TO THE REPORTER, POST-OPERATIVE A VETERINARY PROCEDURE TO THE ABDOMINAL MUSCLE USING A CONTINUOUS SUTURING TECHNIQUE, THE MIDDLE OF THE SUTURE LINE BROKE. THE PATIENT HAD TO BE BROUGHT BACK IN TO REDO THE SUTURE LINE.

  Patient problems: No Code Available

  MAUDE report 8058527 ↗
• MalfunctionNov 11, 2018Break; Break

  ACCORDING TO THE REPORTER, THE SUTURE WAS APPLIED IN A VETERINARY PROCEDURE TO THE ABDOMINAL MUSCLE USING A CONTINUOUS SUTURING TECHNIQUE. POST-OPERATIVELY, THE MIDDLE OF THE SUTURE LINE BROKE. THE PATIENT HAD TO BE BROUGHT BACK IN TO REDO THE SUTURE LINE.

  Patient problems: No Code Available

  MAUDE report 8058524 ↗
• MalfunctionJul 10, 2018Detachment of Device or Device Component; Device Fell; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING TESTING, THE SUTURE FELL OUT OF A SWEDGED NEEDLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7673976 ↗
• MalfunctionJun 20, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THIS WAS AN OUT OF BOX FAILURE WHERE THE SUTURES WITH THE NEEDLES KEPT BREAKING OFF.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7619794 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K000037. One submission often covers many models, so check the product and lot details in each record.

• Z-1299-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 2/0 30"VIOLET GU-46, Item Code UL878 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not
• Z-1286-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 2-0 VIOLET 30" V-20, Item Code GL123 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not
• Z-1300-2020 · Dec 18, 2019 · Terminated
  Biosyn Monofilament Absorbable Suture 6/0 30" VIOLET CV-23, Item Code UM201
• Z-1284-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 1 36 VIOLET GS-21, Item Code CL925 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in
• Z-1294-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture UD 3/0 30 P-14, Item Code SL5679 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in c
• Z-1288-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 2/0 UNDYED 30" V-30 (75CM), Item Code GL228 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, b
• Z-1298-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 0 30" VIOLET GU-46, Item Code UL877 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not i
• Z-1293-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 6/0 18" UNDYED P-10, Item Code SL1625G - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but no
• Z-1279-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 13-0 VIOLET 30" GS-23, Item Code CL892 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but no
• Z-1297-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 4/0 30 VIOLET CVF23, Item Code UL203 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not
• Z-1287-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 0 VIOLET 30" V-20, Item Code GL124 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in
• Z-1278-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 1 30 VIOLET GS-22, Item Code CL885 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in
• Z-1295-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture UD 4/0 18 P-13, Item Code SL5690 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in c
• Z-1277-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 3/0 30 VIOLET GS-11, Item Code CL815 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not
• Z-1291-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 6/0 12"" VL SS-24 D/A, Item Code L1742K - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but n

…and 13 more.