Stratafix SpiralRecalls & reported problems across all models
Surgical Specialties México, S. de R.L. de C.V. · 24 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one Stratafix Spiral model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 118
- Deaths reported
- 0
- Injuries reported
- 63
- Recalls
- 2
We found 24 models of Stratafix Spiral by Surgical Specialties México, S. de R.L. de C.V. in the FDA's device registry (GUDID). Together they are named in 118 adverse event reports in the FDA's MAUDE database, received between Sep 11, 2017 and Aug 5, 2026 — classified as 63 injuries, 55 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (36 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Stratafix Spiral recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Sep 20, 2022Open, Classified
Packages may contain a PS-1 cutting edge needle and not the intended SH taper point needle may result in more tissue trauma than is anticipated for taper point needles, which may necessitate repair
Z-0150-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Mar 24, 2022Open, Classified
Affected product lots may contain the incorrect needle type/size and suture length due to component mix-up.
Z-1053-2022 · Root cause: Employee error · names 2 of these models · Recall details · FDA record ↗
Most reported Stratafix Spiral problems
Device problems
- Detachment of Device or Device Component36
- Break25
- Adverse Event Without Identified Device or Use Problem12
- Material Separation10
- Material Protrusion/Extrusion7
- Device Fell4
- Biocompatibility3
- Device Appears to Trigger Rejection3
Patient problems
- No Clinical Signs, Symptoms or Conditions41
- Foreign Body In Patient30
- Wound Dehiscence7
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available5
- Insufficient Information5
- Ulcer5
- Unspecified Infection5
- Post Operative Wound Infection4
Stratafix Spiral models
24 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Stratafix Spiral SXMD1B405SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall19 reports
- Stratafix Spiral SXMD1B403SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall2 reports
- Stratafix Spiral SXMD1B100SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall1 report
- Stratafix Spiral SXPD1B401SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE23 reports
- Stratafix Spiral SXPD2B405SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE13 reports
- Stratafix Spiral SXPD2B426SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE8 reports
- Stratafix Spiral SXPD2B402SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE6 reports
- Stratafix Spiral SXMD2B402SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID5 reports
- Stratafix Spiral SXMD1B406SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID5 reports
- Stratafix Spiral SXMD1B402SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID5 reports
- Stratafix Spiral SXMD2B412SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID4 reports
- Stratafix Spiral SXPD2B400SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE3 reports
- Stratafix Spiral SXMD2B407SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID3 reports
- Stratafix Spiral SXPD1B400SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE3 reports
- Stratafix Spiral SXPL1B400SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE3 reports
- Stratafix Spiral SXMD2B409SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID2 reports
- Stratafix Spiral SXPD2B412SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE2 reports
- Stratafix Spiral SXMD2B406SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID2 reports
- Stratafix Spiral SXMD2B403SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID2 reports
- Stratafix Spiral SXMD2B408SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID2 reports
- Stratafix Spiral SXPL2B400SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE2 reports
- Stratafix Spiral SXPD2B420SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 report
- Stratafix Spiral SXPD2B410SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 report
- Stratafix Spiral SXPL2B401SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 report
Recent Stratafix Spiral adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 5, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50141449 ↗InjuryJun 10, 2026Break
IT WAS REPORTED ON 8 JUNE 2026 THAT THE SUTURE BROKE INTRAOPERATIVELY. UNSPECIFIED SECONDARY SUTURE INJURIES WERE REPORTED. NO ADDITIONAL INFORMATION WAS RECEIVED.
Patient problems: Insufficient Information
MAUDE report 25460977 ↗InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED ON (B)(6) 2026 THAT ON (B)(6) 2025 A PATIENT HAD A SEROMA POST-OPERATIVELY WHICH WAS TREATED SUCCESSFULLY AND THEN IN (B)(6) 2026 A GRANULOMA FORMED WHICH WAS ALSO TREATED SUCCESSFULLY. NO ADDITIONAL MEDICAL INTERVENTION OR PATIENT INJURY REPORTED.
Patient problems: Seroma
MAUDE report 24916285 ↗MalfunctionApr 1, 2026Break
IT WAS REPORTED ON (B)(6) 2026 THAT DURING A HYSTEROSCOPIC ENDOMETRIAL POLYPECTOMY CERVICAL CONE RESECTION SURGERY THE SUTURE BROKE INTRA-OP CAUSING THE PATIENT'S VAGINAL RESIDUAL END TO BLEED. THE PATIENT WAS IMMEDIATELY REPLACED WITH A NEW SUTURE AND THE SURGERY WAS SUCCESSFULLY COMPLETED. NO ADDITIONAL INJURIES REPORTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24756378 ↗MalfunctionMar 30, 2026Break
IT WAS REPORTED ON MARCH 6 2026 THAT DURING A HYSTEROSCOPIC ENDOMETRIAL POLYPECTOMY CERVICAL CONE RESECTION SURGERY THE SUTURE BROKE INTRA-OP CAUSING THE PATIENT'S VAGINAL RESIDUAL END TO BLEED. THE PATIENT WAS IMMEDIATELY REPLACED WITH A NEW SUTURE AND THE SURGERY WAS SUCCESSFULLY COMPLETED. NO ADDITIONAL INJURIES REPORTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24721396 ↗MalfunctionFeb 9, 2026Material Fragmentation
IT WAS REPORTED ON (B)(6) 2026 THAT DURING A PROCEDURE THE NEEDLE BROKE. ALL THE PIECES WERE RETRIEVED. NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION WAS RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24291537 ↗InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED ON (B)(6) 2025 THAT POST-OPERATIVELY, THE PATIENT EXPERIENCED EXUDATION OF THE WOUND. THE SURGEON RE-SUTURED TO CLOSE THE INCISION. NO OTHER INTERVENTION REQUIRED. IT DOES NOT APPEAR THAT THE ADVERSE REACTION WAS RELATED TO ANY SUTURE DEFECT OR MALFUNCTION.
Patient problems: Fluid Discharge
MAUDE report 23992163 ↗MalfunctionDec 29, 2025Break; Break
IT WAS REPORTED ON (B)(6) 2025 THAT INTRA-OPERATIVELY A SUTURE BROKE, LEADING TO UTERUS BLEEDING. UTERINE HEMOSTASIS WAS ADMINISTERED AND THE SUTURE WAS REPLACED. NO ADDITIONAL INFORMATION WAS RECEIVED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23906860 ↗InjurySep 11, 2025Break; Break
IT WAS REPORTED ON (B)(6) 2025 DURING USE A NEEDLE BROKE. THE PIECES WERE REMOVED AND OEDEMA AND CERVICAL PAIN WERE REPORTED AS SECONDARY EFFECTS. NO ADDITIONAL INFORMATION WAS RECEIVED.
Patient problems: Neck Pain; Swelling/ Edema
MAUDE report 23031873 ↗MalfunctionAug 18, 2025Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE NEEDLE KEPT DESWAGING FROM SUTURE. MINIMAL FORCE WAS USED, AND THE ISSUE OCCURRED WITH MULTIPLE SUTURES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22827800 ↗MalfunctionAug 18, 2025Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE NEEDLE KEPT DESWAGING FROM SUTURE. MINIMAL FORCE WAS USED, AND THE ISSUE OCCURRED WITH MULTIPLE SUTURES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22827798 ↗MalfunctionAug 18, 2025Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE NEEDLE KEPT DESWAGING FROM SUTURE. MINIMAL FORCE WAS USED, AND THE ISSUE OCCURRED WITH MULTIPLE SUTURES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22827796 ↗MalfunctionAug 18, 2025Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE NEEDLE KEPT DESWAGING FROM SUTURE. MINIMAL FORCE WAS USED, AND THE ISSUE OCCURRED WITH MULTIPLE SUTURES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22827792 ↗MalfunctionAug 18, 2025Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE NEEDLE KEPT DESWAGING FROM SUTURE. MINIMAL FORCE WAS USED, AND THE ISSUE OCCURRED WITH MULTIPLE SUTURES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22827787 ↗InjuryAug 11, 2025Break; Break
IT WAS REPORTED ON (B)(6) 2025 THAT POST-OPERATIVELY THE SURGICAL INCISION RUPTURED AND CAUSED BLEEDING. AN ADDITIONAL OPERATION WAS COMPLETED AND THE PATIENT IS REPORTEDLY STABLE. NO OTHER INJURIES REPORTED.
Patient problems: Wound Dehiscence
MAUDE report 22776426 ↗
Other Surgical Specialties México, S. de R.L. de C.V. products
All Surgical Specialties México, S. de R.L. de C.V. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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