ETHICON M656GRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705031045507), received between Nov 29, 2018 and Jun 14, 2024 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 reports).

8 other recalls cover devices cleared under the same FDA submission (K170767, K946173); 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJun 14, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT SUFFERED A RIGHT PATELLAR FRACTURE DUE TO A FALL INJURY AND UNDERWENT AN OPEN REDUCTION AND INTERNAL FIXATION OF RIGHT PATELLAR FRACTURE UNDER GENERAL ANESTHESIA ON (B)(6) 2024 AND SUTURE WAS USED. PRIOR TO THE SURGERY, THE PATIENT WAS INFORMED THAT THE RIGHT KNEE JOINT SHOULD NOT BE EXCESSIVELY FLEXED OR MOVED, AND THAT CRUTCHES SHOULD BE USED WHEN MOVING ON THE GROUND TO MAINTAIN AN EXTENDED POSITION OF THE RIGHT KNEE JOINT. THE RIGHT THIGH SHOULD NOT BE SUBJECTED TO FORCE MOVEMENTS. THE PATIENT MAY HAVE MISUNDERSTOOD POSTOPERATIVE ACTIVITIES, AND MAY NOT BE ACCUSTOMED TO USING THE RESTROOM IN BED. WHEN USING THE RESTROOM ON THE GROUND, THEY MAY HAVE A PARTNER IN THEIR 70S SUPPORTING THEM. AS A RESULT, IT IS IMPOSSIBLE TO ENSURE THAT THEIR RIGHT THIGH DOES NOT EXERT EXCESSIVE FORCE DURING ACTIVITIES, LEADING TO PREMATURE AND EXCESSIVE MOVEMENT . ON THE AFTERNOON OF THE 5TH DAY AFTER SURGERY, THE PATIENT FELT A POPPING SOUND IN THE RIGHT KNEE JOINT ACCOMPANIED BY PAIN. ON THE 6TH DAY AFTER SURGERY, A FOLLOW-UP X-RAY WAS ISSUED. DUE TO WEATHER CONDITIONS, THE PATIENT TOOK A X-RAY BEFORE THE 7TH DAY AFTER SURGERY, WHICH SHOWED THAT THE TENSION BAND STE

  Patient problems: Bone Fracture(s)

  MAUDE report 19538892 ↗
• MalfunctionDec 17, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN REDUCTION AND INTERNAL FIXATION FOR COMMINUTED FRACTURE OF LEFT PATELLA PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED. THE PATIENT RECOVERED WELL. THEN REHABILITATION EXERCISE WAS RECOMMENDED. ON (B)(6) 2018 AT THE TIME OF REEXAMINATION, A STRAND OF SUTURE WAS FOUND BROKEN. THE PATIENT WAS ADVISED TO REDUCE THE INTENSITY OF REHABILITATION EXERCISE. WHEN THE FRACTURE HEALED, THE SURGERY OF REMOVAL OF INTERNAL FIXATION DEVICE FOR LEFT PATELLA FRACTURE WAS PERFORMED ON (B)(6) 2020. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11030803 ↗
• MalfunctionDec 18, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE NEEDLE PULLED OFF THE SUTURE DURING USE. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT. CHANGED ANOTHER ONE TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9490971 ↗
• MalfunctionDec 18, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE NEEDLE PULLED OFF THE SUTURE DURING USE. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT. CHANGED ANOTHER ONE TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9490963 ↗
• MalfunctionApr 26, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE NEEDLE PULLED OFF THE SUTURE DURING USE. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT. CHANGED ANOTHER ONE TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8556185 ↗
• MalfunctionNov 29, 2018Detachment of Device or Device Component

  NEEDLE PULL OFF. IT OCCURRED NEEDLE PULL OFF ISSUE DURING SEWING STERNUM WITH FIRST STITCH IN THE CLOSING THE STERNUM IN EXTRACARDIAC SURGERY. 4 STEEL SUTURES HAS THE SIMILAR ISSUE IN THIS ONE PATIENT, PLEASE HAVE A DEEP INVESTIGATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8117649 ↗
• MalfunctionNov 29, 2018Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A STERNUM CLOSURE IN AN EXTRACARDIAC SURGERY PROCEDURE ON (B)(6) 2018 AND A STEEL SUTURE WAS USED. DURING SURGERY, NEEDLE PULL OFF ISSUE WHILE SEWING STERNUM WITH FIRST STITCH. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8117645 ↗
• MalfunctionNov 29, 2018Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A STERNUM CLOSURE IN AN EXTRACARDIAC SURGERY PROCEDURE ON (B)(4) 2018 AND A STEEL SUTURE WAS USED. DURING SURGERY, NEEDLE PULL OFF ISSUE WHILE SEWING STERNUM WITH FIRST STITCH. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8117644 ↗
• MalfunctionNov 29, 2018Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A STERNUM CLOSURE IN AN EXTRACARDIAC SURGERY PROCEDURE ON (B)(6) 2018 AND A STEEL SUTURE WAS USED. DURING SURGERY, NEEDLE PULL OFF ISSUE WHILE SEWING STERNUM WITH FIRST STITCH. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8117642 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K170767, K946173. One submission often covers many models, so check the product and lot details in each record.

• Z-1516-2025 · Mar 7, 2025 · Open, Classified
  ETHIBOND EXCEL GRN 36IN(90CM) USP2-0(M3) D/A MH
• Z-1097-2025 · Dec 20, 2024 · Open, Classified
  PERMA-HAND Silk Suture, REF: K872H, W723H, 623H, K833H; Perma-hand Silk Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovas
• Z-2486-2020 · Jun 10, 2020 · Open, Classified
  PERMA-HAND/MERSILK SILK BLU and VIRGIN SILK BLU, Product Codes EH7457G EH7983G FV768 FV769 FV7771 U7058 U7059 W1782 W1784 W1819 W1820 W818 W819 W870
• Z-1842-2019 · Apr 19, 2019 · Terminated
  ETHIBOND EXCEL ETHIBOND Polvester Suture-Green 75cm USP1 Single Armed CTX Product Code: X865W Product Usage: ETHIBOND EXCEL Suture is intended for use in general soft tissue appr
• Z-1841-2019 · Apr 19, 2019 · Terminated
  ETHIBOND EXCEL Polyester Suture-ETHIBOND Green 75cm USP1 Single Armed CT-1 Product Code: X425H Product Usage: ETHIBOND EXCEL Suture is intended for use in general soft tissue app
• Z-0747-2019 · Dec 18, 2018 · Terminated
  PERMA-HAND Silk Suture Size 5, Black 30" (75cm) Double Armed LR Needles, Product Code 485T Product Usage: PERMA-HAND* suture is indicated for use in general soft tissue approxima
• Z-1839-2015 · May 8, 2015 · Terminated
  Ethicon Fast Absorbing Plain Gut - MultiPass Needles, Sterile, Absorbable Surgical Suture, 5-0 (1.5 metric), 18" (45 cm), Conventional Cutting, Lot #JD6163, Exp: July 2019. Fast ab
• Z-0492-2015 · Oct 17, 2014 · Terminated
  Ethicon PERMA-HAND Silk siliconized black braided 10 strands per packet Ethicon LLC- Made in USA.