Biosyn GM-322Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10884521032699), received between Oct 31, 2017 and Dec 2, 2025 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2025Break; Break

  IT WAS REPORTED THAT INTRAOPERATIVELY, TWO SUTURES BROKE WHILE BEING USED BY THE SURGEON, WITH BOTH INSTANCES OCCURRING IN THE MIDDLE OF THE SUTURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23696822 ↗
• MalfunctionDec 2, 2025Break; Break

  IT WAS REPORTED THAT INTRAOPERATIVELY, TWO SUTURES BROKE WHILE BEING USED BY THE SURGEON, WITH BOTH INSTANCES OCCURRING IN THE MIDDLE OF THE SUTURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23694398 ↗
• MalfunctionNov 19, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN OPEN BREAST PROCEDURE, THE NEEDLE BENT AND A BREAK OCCURRED DURING SUTURING OF BOTH THE SKIN AND BREAST TISSUE. A NEW SUTURE 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 23591867 ↗
• MalfunctionAug 22, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, DURING THE USE OF THE SUTURE, THE THREAD CAME LOOSE FROM THE NEEDLE.

  Patient problems: Insufficient Information

  MAUDE report 17597158 ↗
• InjuryJun 3, 2021Use of Device Problem; Detachment of Device or Device Component; Device Contamination with Chemical or Other Material; Material Protrusion/Extrusion; Use of Device Problem; Detachment of Device or Device Component; Device Contamination with Chemical or Other Material; Material Protrusion/Extrusion

  ACCORDING TO THE REPORTER, WHEN CLOSING THE DEEP DERMAL LAYER DURING AN OPEN ANTERIOR CERVICAL REPAIR, THE NEEDLE WAS CATCHING AS IT WAS BEING PASSED THROUGH THE TISSUE. IT WAS NOTED THAT THE NEEDLE WAS NOT SMOOTH AND UPON LOOKING CLOSER, THE NEEDLE LOOKED IT HAD FRAYED. IT WAS STATED THAT THE NEEDLE WAS FRAYED ENOUGH THAT IT COULD CAUSE ADDITIONAL TRAUMA TO THE PATIENT WHEN BEING PASSED THROUGH. THERE WERE ALSO ¿SHAVINGS¿ THAT SEEMED TO BE COMING OFF THE NEEDLE THAT WERE LEFT BEHIND IN THE PATIENT. THE MALFUNCTION WAS DISCOVERED ON TWO NEEDLES. ANOTHER ONE WAS OPENED TO COMPLETE THE CASE.

  Patient problems: Foreign Body In Patient

  MAUDE report 11930449 ↗
• MalfunctionOct 23, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING ROBOTIC LAPAROSCOPIC SURGERY, THE NEEDLE WAS POPPING OFF THE THREAD. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10725865 ↗
• MalfunctionJul 16, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN HYDROCELECTOMY, THE DEVICE THREAD BROKE. THE SURGEON THEN USED ANOTHER SUTURE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8794605 ↗
• MalfunctionJun 26, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING A WOUND CLOSURE ON A FOOT KIDNER PROCEDURE, THE SUTURE BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8737610 ↗
• InjuryApr 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT HAD A KNOT ABSCESS FOLLOWING A DIAGNOSTIC ARTHROSCOPY. THE SURGEON REMOVED THE STITCH TO COMPLETE THE CASE.

  Patient problems: Abscess

  MAUDE report 8544914 ↗
• MalfunctionApr 9, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN TENDON EXTENSION PROCEDURE, WHILE THE DEVICE WAS BEING USED FOR CLOSING USING A RUNNING SUTURING TECHNIQUE, THE THREAD OF THE SUTURES BROKE. THEY OPENED A NEW DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8497901 ↗
• MalfunctionMar 18, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING OPEN BREAST MASTECTOMY, WHILE CLOSING SUBCUTICULAR LAYER NEAR THE BREAST AREA, THE TWO SUTURES CAME OFF FROM THE SWAGE AFTER TAKING 2 OR 3 BITES. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8428233 ↗
• MalfunctionOct 31, 2017Detachment Of Device Component; Detachment of Device or Device Component; Detachment Of Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER: OCCURRED DURING A CESAREAN SECTION PROCEDURE. THE SUTURE WAS BEING USED TO CLOSE THE SKIN OF THE PATIENT USING THE SUBCUTICULAR CLOSURE. THE NEEDLE SEPARATED FROM THE THREAD DURING THE CLOSURE. IN ORDER TO RESOLVE THE ISSUE AND COMPLETE THE CASE, THEY STOPPED SUTURING, REMOVED THE NEEDLE FROM THE PATIENT, AND OPENED ANOTHER PACK OF SUTURE TO FINISH THE CLOSURE. THERE WAS NO PATIENT HARM. THE PATIENT OUTCOME IS ALIVE, NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6990373 ↗

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-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-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-1280-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 2 36" VIOLET GS-24, Item Code CL911 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not i
• 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-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-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-1282-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 1 36 VIOLET GS-24, Item Code CL915 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in
• Z-1275-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 0 30" UNDYED HOS-11, Item Code CL537 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not
• Z-1274-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 3/0 VIOLET 30" CV-24 (75CM), Item Code CL461 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery,
• 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-1283-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 2-0 VIOLET 36" GS-21, Item Code CL923 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not
• Z-1296-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 4/0 30 VIO SC-2 124K, Item Code SL654 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not
• 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-1292-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 6-0 18" UNDYED SS-24 D/A, Item Code L2752K - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, bu
• Z-1290-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 3/0 30" UNDYED V-20, Item Code GLS322 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not

…and 13 more.