ETHICON 770GRecalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10705031010475), received between Jun 25, 2018 and Aug 12, 2026 — classified as 2 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Break” (9 reports).

8 other recalls cover devices cleared under the same FDA submission (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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50221211 ↗
• InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A FACELIFT PROCEDURE ON AN UNKNOWN DATE ON (B)(6) 2025 AND SUTURE WAS USED. POST-OP, THE PATIENT DEVELOPED AN INFECTION. THE ORGANISM IS RARELY FOUND IN HUMANS AND IS MORE COMMONLY ASSOCIATED WITH CATTLE. THE PATIENT REQUIRED UNKNOWN MEDICAL OR SURGICAL INTERVENTION AS A RESULT OF THE EVENT. THE PATIENT DID NOT REQUIRE EXTENDED HOSPITALIZATION AS A RESULT OF THE EVENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 24273649 ↗
• InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A FACELIFT PROCEDURE ON AN UNKNOWN DATE IN (B)(6) 2025 AND SUTURE WAS USED. POST-OP, THE PATIENT DEVELOPED AN INFECTION. THE ORGANISM IS RARELY FOUND IN HUMANS AND IS MORE COMMONLY ASSOCIATED WITH CATTLE. THE PATIENT REQUIRED UNKNOWN MEDICAL OR SURGICAL INTERVENTION AS A RESULT OF THE EVENT. THE PATIENT DID NOT REQUIRE EXTENDED HOSPITALIZATION AS A RESULT OF THE EVENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 24273631 ↗
• MalfunctionAug 21, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPHTHALMIC SURGERY ON (B)(6) 2025 AND SUTURE WAS USED. DURING SURGERY AS THE SURGEON BITE WITH SUTURE AND PULL OFF THE NEEDLE CAME OFF ON THE SUTURE. OPEN ANOTHER THREE SET BOX OF SUTURE WITH THE SAME RESULT. THERE WERE NO PATIENT ADVERSE EVENT. PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22860414 ↗
• MalfunctionAug 21, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPHTHALMIC SURGERY ON (B)(6) 2025 AND SUTURE WAS USED. DURING SURGERY AS THE SURGEON BITE WITH SUTURE AND PULL OFF THE NEEDLE CAME OFF ON THE SUTURE. OPEN ANOTHER THREE SET BOX OF SUTURE WITH THE SAME RESULT. THERE WERE NO PATIENT ADVERSE EVENT. PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22860088 ↗
• MalfunctionAug 21, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPHTHALMIC SURGERY ON (B)(6) 2025 AND SUTURE WAS USED. DURING SURGERY AS THE SURGEON BITE WITH SUTURE AND PULL OFF THE NEEDLE CAME OFF ON THE SUTURE. OPEN ANOTHER THREE SET BOX OF SUTURE WITH THE SAME RESULT. THERE WERE NO PATIENT ADVERSE EVENT. PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22860080 ↗
• MalfunctionAug 21, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPHTHALMIC SURGERY ON (B)(6) 2025 AND SUTURE WAS USED. DURING SURGERY AS THE SURGEON BITE WITH SUTURE AND PULL OFF THE NEEDLE CAME OFF ON THE SUTURE. OPEN ANOTHER THREE SET BOX OF SUTURE WITH THE SAME RESULT. THERE WERE NO PATIENT ADVERSE EVENT. PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22860073 ↗
• MalfunctionApr 3, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EYELID PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT OCULOPLASTIC SURGEON USES A SUTURE FOR OCULOPLASTIC SURGERY. DURING SURGERY THE NEEDLE WAS PULLING OFF EVERY SUTURE SHE USED (3 DIFFERENT ONES FROM THIS BOX). THEY TOOK THIS BOX OUT OF USE AND GOT ANOTHER ONE WITH A DIFFERENT LOT NUMBER AND IT WORKED FINE. SURGEON USES THIS SUTURE ALL THE TIME SO THEY DO NOT FEEL IT IS HER TECHNIQUE. THEY TRIED 3 DIFFERENT SUTURES FROM THIS BOX THEN PULLED THIS BOX OUT OF USE AND USED SUTURES FROM A BOX WITH A DIFFERENT LOT NUMBER. PROCEDURE WAS COMPLETED WITH A DELAY OF 5-10 MINUTES. NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21762540 ↗
• MalfunctionApr 3, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EYELID PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT OCULOPLASTIC SURGEON USES A SUTURE FOR OCULOPLASTIC SURGERY. DURING SURGERY THE NEEDLE WAS PULLING OFF EVERY SUTURE SHE USED (3 DIFFERENT ONES FROM THIS BOX). THEY TOOK THIS BOX OUT OF USE AND GOT ANOTHER ONE WITH A DIFFERENT LOT NUMBER AND IT WORKED FINE. SURGEON USES THIS SUTURE ALL THE TIME SO THEY DO NOT FEEL IT IS HER TECHNIQUE. THEY TRIED 3 DIFFERENT SUTURES FROM THIS BOX THEN PULLED THIS BOX OUT OF USE AND USED SUTURES FROM A BOX WITH A DIFFERENT LOT NUMBER. PROCEDURE WAS COMPLETED WITH A DELAY OF 5-10 MINUTES. NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21762520 ↗
• MalfunctionApr 3, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EYELID PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT OCULOPLASTIC SURGEON USES A SUTURE FOR OCULOPLASTIC SURGERY. DURING SURGERY THE NEEDLE WAS PULLING OFF EVERY SUTURE SHE USED (3 DIFFERENT ONES FROM THIS BOX). THEY TOOK THIS BOX OUT OF USE AND GOT ANOTHER ONE WITH A DIFFERENT LOT NUMBER AND IT WORKED FINE. SURGEON USES THIS SUTURE ALL THE TIME SO THEY DO NOT FEEL IT IS HER TECHNIQUE. THEY TRIED 3 DIFFERENT SUTURES FROM THIS BOX THEN PULLED THIS BOX OUT OF USE AND USED SUTURES FROM A BOX WITH A DIFFERENT LOT NUMBER. PROCEDURE WAS COMPLETED WITH A DELAY OF 5-10 MINUTES. NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21762516 ↗
• MalfunctionFeb 15, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A EYE LID PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE BLEPHAROPLASTY, THE LINE STRING PART WAS BREAKING. SEVERAL SUTURES WERE ATTEMPTED FROM THE SAME BOX. CASE WAS COMPLETED WITH A LIKE DEVICE. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18712731 ↗
• MalfunctionFeb 15, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A EYE LID PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE BLEPHAROPLASTY, THE LINE STRING PART WAS BREAKING. SEVERAL SUTURES WERE ATTEMPTED FROM THE SAME BOX. CASE WAS COMPLETED WITH A LIKE DEVICE. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18712730 ↗
• MalfunctionDec 11, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THERE WAS AN ISSUE WITH THE SUTURE DISSOLVING FASTER THAN IT NORMALLY SHOULD. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18307693 ↗
• MalfunctionDec 11, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THERE WAS AN ISSUE WITH THE SUTURE DISSOLVING FASTER THAN IT NORMALLY SHOULD. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18307692 ↗
• MalfunctionDec 11, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THERE WAS AN ISSUE WITH THE SUTURE DISSOLVING FASTER THAN IT NORMALLY SHOULD. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18307682 ↗
• MalfunctionDec 11, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THERE WAS AN ISSUE WITH THE SUTURE DISSOLVING FASTER THAN IT NORMALLY SHOULD. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18307678 ↗
• MalfunctionNov 17, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THERE WAS AN ISSUE WITH THE SUTURE DISSOLVING FASTER THAN IT NORMALLY SHOULD. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18160577 ↗
• MalfunctionAug 31, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2021 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED THAT A HAIR WAS FOUND INSIDE THE PACKAGING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12398537 ↗
• MalfunctionNov 20, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EYE PROCEDURE ON AN UNKNOWN DATE BETWEEN (B)(6) 2020 AND (B)(6) 2020, AND THE SUTURE WAS USED INTERRUPTED AND TIED WITH SQUARE KNOT ON NORMAL PEDIATRIC CONJUNCTIVA TISSUE. THE SUTURE WAS NOT HOLDING ITS KNOTS AND COMING UNTIED IN THE IMMEDIATE POST-OP PERIOD. THERE WAS NO PRECIPITATING STRESS FACTOR FOR THE SUTURE UNTYING. THE PATIENT EXPERIENCED OPEN CONJUNCTIVAL INCISION AND DID NOT REQUIRE RE-SUTURING. THE DOCTOR OPINED THAT IT IS UNCLEAR WHY THE SUTURE WAS NOT HOLDING KNOT AND COMING UNTIED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 10879806 ↗
• MalfunctionNov 20, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EYE PROCEDURE ON AN UNKNOWN DATE BETWEEN (B)(6) 2020 AND (B)(6) 2020 AND THE SUTURE WAS USED INTERRUPTED AND TIED WITH SQUARE KNOT ON NORMAL PEDIATRIC CONJUNCTIVA TISSUE. THE SUTURE WAS NOT HOLDING ITS KNOTS AND COMING UNTIED IN THE IMMEDIATE POST-OP PERIOD. THERE WAS NO PRECIPITATING STRESS FACTOR FOR THE SUTURE UNTYING. THE PATIENT EXPERIENCED GRANULOMA FORMATION AND DID NOT REQUIRE RE-SUTURING. THE DOCTOR OPINED THAT IT IS UNCLEAR WHY THE SUTURE WAS NOT HOLDING KNOT AND COMING UNTIED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Granuloma

  MAUDE report 10879788 ↗
• MalfunctionNov 20, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EYE PROCEDURE ON AN UNKNOWN DATE BETWEEN (B)(6) 2020, AND THE SUTURE WAS USED INTERRUPTED, AND TIED WITH SQUARE KNOT ON NORMAL PEDIATRIC CONJUNCTIVA TISSUE. THE SUTURE WAS NOT HOLDING ITS KNOTS AND COMING UNTIED IN THE IMMEDIATE POST-OP PERIOD. THERE WAS NO PRECIPITATING STRESS FACTOR FOR THE SUTURE UNTYING. THE PATIENT HEALED OKAY, AND DID NOT REQUIRE RE-SUTURING. THE DOCTOR OPINED THAT IT IS UNCLEAR WHY THE SUTURE WAS NOT HOLDING KNOT AND COMING UNTIED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10879724 ↗
• MalfunctionNov 20, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EYE PROCEDURE ON AN UNKNOWN DATE BETWEEN (B)(6) 2020 AND (B)(6) 2020 AND THE SUTURE WAS USED INTERRUPTED AND TIED WITH SQUARE KNOT ON NORMAL PEDIATRIC CONJUNCTIVA TISSUE. THE SUTURE WAS NOT HOLDING ITS KNOTS AND COMING UNTIED IN THE IMMEDIATE POST-OP PERIOD. THERE WAS NO PRECIPITATING STRESS FACTOR FOR THE SUTURE UNTYING. THE PATIENT EXPERIENCED CYST AND DID NOT REQUIRE RE-SUTURING. THE DOCTOR OPINED THAT IT IS UNCLEAR WHY THE SUTURE WAS NOT HOLDING KNOT AND COMING UNTIED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Cyst(s)

  MAUDE report 10879703 ↗
• MalfunctionOct 15, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE WAS NOT HOLDING ITS KNOTS AND COMING UNTIED IN THE IMMEDIATE POST-OP PERIOD. DESPITE REDOING SUTURES MULTIPLE TIMES INTRAOPERATIVELY, AND DOUBLE CHECKING BEFORE CLOSING. IT IS NOT DUE TO PROBLEMS THROWING SUTURE OR CHEESEWIRING. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 10687741 ↗
• MalfunctionSep 21, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. FOLLOWING THE PROCEDURE, THE SUTURE BECAME UNTIED IN THE IMMEDIATE POST-OP PERIOD. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10564669 ↗
• MalfunctionNov 21, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PTOSIS PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED. DURING USE, THE NEEDLE POPPED OFF WITHOUT ANY TENSION. CASE COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8094204 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under 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.