STRATAFIX SXMP1B435Recalls & reported problems

Ethicon, LLC · Knotless Tissue Control Device, Undyed Unidirectional (Antibacterial) Synthetic Absorbable Device · Class 2 · Implant

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports: 6
Deaths reported: 0
Injuries reported: 6
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705031236462), received between Jan 4, 2018 and Feb 6, 2018 — classified as 6 injuries.

The most frequently reported specific device problem is “Failure To Adhere Or Bond” (6 reports).

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

Device problems

Failure To Adhere Or Bond6
Appropriate Device Problem Term/Code Not Available3

Patient problems

Wound Dehiscence6
No Code Available5
Reaction3
Not Applicable1

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

InjuryFeb 6, 2018Failure To Adhere Or Bond; Appropriate Device Problem Term/Code Not Available; Failure To Adhere Or Bond; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT A PATIENT UNDERWENT HAND SURGEON ON (B)(6) 2017 AND BARBED SUTURE WAS USED ON SUBCUTANEOUS TISSUE AND SKIN. POST OPERATIVELY, THE PATIENT EXPERIENCED WOUND DEHISCENCE WITHIN 3 WEEKS OF THE PROCEDURE. THE SURGEON REPORTED THE DEVICE LOST FIXATION STRENGTH. THE SURGEON OPINED THAT THE COATING ON SUTURES LED TO POOR FIXATION AND WHAT SEEMED TO BE A REACTION AND RELEASE OF HEALING TISSUE. AN ADDITIONAL PROCEDURE WAS PERFORMED TO RE-APPROXIMATE THE WOUND ON AN UNKNOWN DATE WITH A DIFFERENT SUTURE TYPE. THE PATIENT IS REPORTED AS FINE. ADDITIONAL INFORMATION WILL BE REQUESTED.
Patient problems: Not Applicable; Reaction; Wound Dehiscence
MAUDE report 7243801 ↗
InjuryFeb 6, 2018Failure To Adhere Or Bond; Appropriate Device Problem Term/Code Not Available; Failure To Adhere Or Bond; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT A PATIENT UNDERWENT HAND SURGEON ON (B)(6) 2017 AND BARBED SUTURE WAS USED ON SUBCUTANEOUS TISSUE AND SKIN. POST OPERATIVELY, THE PATIENT EXPERIENCED WOUND DEHISCENCE WITHIN 3 WEEKS OF THE PROCEDURE. THE SURGEON REPORTED THE DEVICE LOST FIXATION STRENGTH. THE SURGEON OPINED THAT THE COATING ON SUTURES LED TO POOR FIXATION AND WHAT SEEMED TO BE A REACTION AND RELEASE OF HEALING TISSUE. AN ADDITIONAL PROCEDURE WAS PERFORMED TO RE-APPROXIMATE THE WOUND ON AN UNKNOWN DATE WITH A DIFFERENT SUTURE TYPE. THE PATIENT IS REPORTED AS FINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Code Available; Reaction; Wound Dehiscence
MAUDE report 7243742 ↗
InjuryFeb 6, 2018Failure To Adhere Or Bond; Appropriate Device Problem Term/Code Not Available; Failure To Adhere Or Bond; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT A PATIENT UNDERWENT HAND SURGEON ON (B)(6) 2017 AND BARBED SUTURE WAS USED ON SUBCUTANEOUS TISSUE AND SKIN. POST OPERATIVELY, THE PATIENT EXPERIENCED WOUND DEHISCENCE WITHIN 3 WEEKS OF THE PROCEDURE. THE SURGEON REPORTED THE DEVICE LOST FIXATION STRENGTH. THE SURGEON OPINED THAT THE COATING ON SUTURES LED TO POOR FIXATION AND WHAT SEEMED TO BE A REACTION AND RELEASE OF HEALING TISSUE. AN ADDITIONAL PROCEDURE WAS PERFORMED TO RE-APPROXIMATE THE WOUND ON AN UNKNOWN DATE WITH A DIFFERENT SUTURE TYPE. THE PATIENT IS REPORTED AS FINE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Code Available; Reaction; Wound Dehiscence
MAUDE report 7243705 ↗
InjuryJan 8, 2018Failure To Adhere Or Bond; Failure To Adhere Or Bond
IT WAS REPORTED THAT THE PATIENT UNDERWENT A VASCULAR PROCEDURE ON UNKNOWN DATE AND BARBED SUTURE WAS USED. POST-OPERATIVELY, THE DEVICE LOST FIXATION STRENGTH AND THE PATIENT EXPERIENCED WOUND DEHISCENCE. AN ADDITIONAL PROCEDURE WAS PERFORMED TO RE-APPROXIMATE THE WOUND WITH A DIFFERENT TYPE OF SUTURE. THE PATIENT IS REPORTED AS FINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Code Available; Wound Dehiscence
MAUDE report 7171569 ↗
InjuryJan 8, 2018Failure To Adhere Or Bond; Failure To Adhere Or Bond
IT WAS REPORTED THAT THE PATIENT UNDERWENT A VASCULAR PROCEDURE ON UNKNOWN DATE AND BARBED SUTURE WAS USED. POST-OPERATIVELY, THE DEVICE LOST FIXATION STRENGTH AND THE PATIENT EXPERIENCED WOUND DEHISCENCE. AN ADDITIONAL PROCEDURE WAS PERFORMED TO RE-APPROXIMATE THE WOUND WITH A DIFFERENT TYPE OF SUTURE. THE PATIENT IS REPORTED AS FINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Code Available; Wound Dehiscence
MAUDE report 7171527 ↗
InjuryJan 4, 2018Failure To Adhere Or Bond; Failure To Adhere Or Bond
IT WAS REPORTED THAT THE PATIENT UNDERWENT A VASCULAR PROCEDURE ON UNKNOWN DATE AND BARBED SUTURE WAS USED. POST-OPERATIVELY, THE DEVICE LOST FIXATION STRENGTH AND THE PATIENT EXPERIENCED WOUND DEHISCENCE. AN ADDITIONAL PROCEDURE WAS PERFORMED TO RE-APPROXIMATE THE WOUND WITH A DIFFERENT TYPE OF SUTURE. THE PATIENT IS REPORTED AS FINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Code Available; Wound Dehiscence
MAUDE report 7166403 ↗

Device details

UDI-DI	`10705031236462`
Brand	STRATAFIX
Model	SXMP1B435
Company	Ethicon, LLC
Product code	GAM · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
Class	Class 2
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Safe
Status	In Commercial Distribution
Record updated	Jul 20, 2023

Device type (GMDN): Barbed polyester suture, antimicrobial

A single-strand (monofilament), synthetic, bioabsorbable thread made from a polyester, and containing an agent to locally inhibit bacterial growth, intended to approximate the edges of a soft-tissue wound or incision by stitching. It is designed with barbs along its length intended to facilitate tissue approximation by adding tension, a fixation feature (e.g., tab, loop, bidirectional barbs) intended to eliminate the need to tie a knot, and may include disposable suture application devices [e.g., needle, passer]. The thread provides extended temporary wound support, until the wound sufficiently heals to withstand normal stress, and is absorbed by hydrolysis. This is a single-use device.

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Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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