ETHIBOND EXCEL MX551Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705031047112), received between Jul 26, 2019 and Jul 26, 2019 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA CLINICAL TRIAL THAT THE PATIENT UNDERWENT EXCISION OF BRAIN TUMOR DURING CRANIOTOMY ON (B)(6) 2019 AND SUTURE WAS USED ON THE ENDOCRANIUM. IT WAS REPORTED THAT THE OPERATION WAS SUCCESSFUL. THE PATIENT EXPERIENCED FEVER ON (B)(6) 2019 WITH HIGHEST TEMPERATURE OF 38.8. MEROPENEM WAS GIVEN AS ANTI-INFLAMMATORY THERAPY AND PHYSICAL COOLING. LUMBAR PUNCTURE DRAINAGE AND CEREBROSPINAL FLUID EXAMINATION CONDUCTED ON (B)(6) 2019. DUE TO PATIENT HAD FEVER AND ABNORMAL CEREBROSPINAL FLUID EXAMINATION, PATIENT WAS DIAGNOSED WITH SUSPECTED OF THE CENTRAL NERVOUS SYSTEM INFECTION. THE PATIENT¿S HOSPITALIZATION WAS EXTENDED FOR FURTHER DIAGNOSIS AND TREATMENT. THE PATIENT'S TEMPERATURE RETURNED TO NORMAL ON (B)(6) 2019. IT WAS REPORTED THAT THE PATIENTS SYMPTOMS RESOLVED WITH TREATMENT AND CONTINUATION OF DRUGS. IT WAS REPORTED THAT THE RELATIONSHIP TO THE INVESTIGATIONAL PRODUCT WAS NOT RELATED AND RELATIONSHIP TO SURGICAL PROCEDURE WAS PROBABLY RELATED. THE PATIENT WAS DISCHARGED ON (B)(6) 2019 WITH INSTRUCTIONS TO CONTINUE LOW MOLECULAR WEIGHT HEPARIN ANTICOAGULANT THERAPY AFTER DISCHARGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 8833638 ↗

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.