STRATAFIXRecalls & reported problems across all models
Ethicon, LLC · 181 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 model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 7,673
- Deaths reported
- 2
- Injuries reported
- 1,142
- Recalls
- 7
We found 181 models of STRATAFIX by Ethicon, LLC in the FDA's device registry (GUDID). Together they are named in 7,673 adverse event reports in the FDA's MAUDE database, received between Nov 20, 2017 and Sep 30, 2026 — classified as 2 deaths, 1,142 injuries, 6,529 malfunctions.
The most frequently reported specific device problem is “Break” (4,135 reports).
7 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 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.
- Aug 15, 2025Open, Classified
Potential for barb non-engagement.
Z-2605-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Mar 8, 2024Open, Classified
Degraded and unusable upon removal from the foil pouch due to exposed environmental conditions during transit and storage, compromising sterility
Z-1533-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Aug 28, 2019Terminated
The product do not meet certain internal testing specifications.
Z-1336-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Aug 28, 2019Terminated
The product do not meet certain internal testing specifications.
Z-1335-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Aug 28, 2019Terminated
The product do not meet certain internal testing specifications.
Z-1334-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Aug 13, 2019Terminated
The product does not meet certain internal strength testing specifications.
Z-0048-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Aug 13, 2019Terminated
The product does not meet certain internal strength testing specifications.
Z-0047-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported STRATAFIX problems
Device problems
- Break4,135
- Material Separation1,832
- Adverse Event Without Identified Device or Use Problem748
- Positioning Failure471
- Material Integrity Problem321
- Material Frayed80
- Positioning Problem63
- Defective Component55
Patient problems
- No Clinical Signs, Symptoms or Conditions5,347
- No Consequences Or Impact To Patient1,058
- Wound Dehiscence624
- Unspecified Infection220
- Not Applicable214
- Insufficient Information125
- Pocket Erosion103
- Impaired Healing101
STRATAFIX models
181 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- STRATAFIX SXPP1A405SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE617 reports
- STRATAFIX SXPP1A400SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE485 reports
- STRATAFIX SXPP1A401SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE446 reports
- STRATAFIX SXPP1A301SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE443 reports
- STRATAFIX SXPP2B405Suture, surgical, absorbable, polydioxanone406 reports
- STRATAFIX SXPP1A406SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE339 reports
- STRATAFIX SXPP1A404SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 death319 reports
- STRATAFIX SXPP1B420SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 death229 reports
- STRATAFIX SXPP1B450SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE206 reports
- STRATAFIX SXPP1B410SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE200 reports
- STRATAFIX SXPP1A403SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE173 reports
- STRATAFIX SXPP1A445SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE143 reports
- STRATAFIX SXPP1B113SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE131 reports
- STRATAFIX SXMP1B427SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID114 reports
- STRATAFIX SXPP1A300SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE113 reports
- STRATAFIX SXPP1A201SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE113 reports
- STRATAFIX SXPP2B400Suture, surgical, absorbable, polydioxanone1 recall54 reports
- STRATAFIX SXPP1B105SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE102 reports
- STRATAFIX SXPP1B455SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE96 reports
- STRATAFIX SXPP1B456SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE88 reports
- STRATAFIX SXPP1B453SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE87 reports
- STRATAFIX SXMP1B103SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID83 reports
- STRATAFIX SXMP2B412SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall33 reports
- STRATAFIX SXPP1A444SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE73 reports
- STRATAFIX SXPP1B407SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE70 reports
- STRATAFIX SXPP1B112SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE68 reports
- STRATAFIX SXPP1A205SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE65 reports
- STRATAFIX SXPP2B436Suture, surgical, absorbable, polydioxanone64 reports
- STRATAFIX SXPP1A203SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE62 reports
- STRATAFIX SXMP1B413SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID55 reports
- STRATAFIX SXPP1B401SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 recall4 reports
- STRATAFIX SXPP1B402SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 recall4 reports
- STRATAFIX SXPP1B430SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 recall3 reports
- STRATAFIX SXMP1B421SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID53 reports
- STRATAFIX SXMP1B117SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID53 reports
- STRATAFIX SXPP2B412Suture, surgical, absorbable, polydioxanone53 reports
- STRATAFIX SXPP1B429SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 recall2 reports
- STRATAFIX SXPP1B201SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 recall0 reports
- STRATAFIX SXPP1B406SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE49 reports
- STRATAFIX SXPP1B409SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE49 reports
- STRATAFIX SXPP2B101Suture, surgical, absorbable, polydioxanone49 reports
- STRATAFIX SXMP1B119SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID48 reports
- STRATAFIX SXPP1B412SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE46 reports
- STRATAFIX SXMP1B409SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID46 reports
- STRATAFIX SXPP1B104SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE44 reports
- STRATAFIX SXMP1B101SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID43 reports
- STRATAFIX SXPP1A433SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE43 reports
- STRATAFIX SXPP1A410SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE42 reports
- STRATAFIX SXPP1A425SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE42 reports
- STRATAFIX SXPP1B416SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE40 reports
- STRATAFIX SXPP1A101SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE39 reports
- STRATAFIX SXPP1A443SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE38 reports
- STRATAFIX SXPP1B411SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE37 reports
- STRATAFIX SXPP1B415SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE35 reports
- STRATAFIX SXPP1B427SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE35 reports
- STRATAFIX SXPP1B432SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE35 reports
- STRATAFIX SXPP1B422SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE33 reports
- STRATAFIX SXMP1B102SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID32 reports
- STRATAFIX SXMP1B111SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID32 reports
- STRATAFIX SXMP1B414SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID31 reports
- STRATAFIX SXMP2B409SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID31 reports
- STRATAFIX SXPP1B433SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE30 reports
- STRATAFIX SXMP2B402SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID30 reports
- STRATAFIX SXPP1A432SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE29 reports
- STRATAFIX SXPP1B119SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE27 reports
- STRATAFIX SXPP2B202Suture, surgical, absorbable, polydioxanone27 reports
- STRATAFIX SXPP2B203Suture, surgical, absorbable, polydioxanone27 reports
- STRATAFIX SXPP1A407SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE26 reports
- STRATAFIX SXMP1B118SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID25 reports
- STRATAFIX SXPP1A435SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE25 reports
- STRATAFIX SXPP1B454SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE23 reports
- STRATAFIX SXMP1B452Suture, absorbable, synthetic, polyglycolic acid23 reports
- STRATAFIX SXPP1A306SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE22 reports
- STRATAFIX SXPP1B457SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE21 reports
- STRATAFIX SXMP1B109SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID20 reports
- STRATAFIX SXPP2B201Suture, surgical, absorbable, polydioxanone20 reports
- STRATAFIX SXPP1A200SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE19 reports
- STRATAFIX SXPP1B408SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE19 reports
- STRATAFIX SXPP2B423Suture, surgical, absorbable, polydioxanone19 reports
- STRATAFIX SXPP1B405SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE18 reports
- STRATAFIX SXMP2B411SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID18 reports
- STRATAFIX SXPP2B409Suture, surgical, absorbable, polydioxanone18 reports
- STRATAFIX SXPP1A100SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE17 reports
- STRATAFIX SXPP1B404SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE17 reports
- STRATAFIX SXMP1B424SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID17 reports
- STRATAFIX SXMP1B434SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID17 reports
- STRATAFIX SXPP1A402SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE16 reports
- STRATAFIX SXPP1A408SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE16 reports
- STRATAFIX SXPP1B419SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE16 reports
- STRATAFIX SXPP1A446SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE16 reports
- STRATAFIX SXPP1A441SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE15 reports
- STRATAFIX SXMP2B405SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID15 reports
- STRATAFIX SXPP1A422SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE14 reports
- STRATAFIX SXPP1A423SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE14 reports
- STRATAFIX SXMP1B107SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID13 reports
- STRATAFIX SXMP1B108SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID13 reports
- STRATAFIX SXMP2B408SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID13 reports
- STRATAFIX SXMP2B406SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID13 reports
- STRATAFIX SXPP1A409SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE12 reports
- STRATAFIX SXPP1A302SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE11 reports
Recent STRATAFIX adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Break; Product Quality Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950946 ↗MalfunctionSep 30, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950668 ↗MalfunctionSep 30, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950068 ↗MalfunctionSep 30, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950062 ↗MalfunctionSep 30, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950051 ↗MalfunctionSep 30, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949642 ↗MalfunctionSep 30, 2026Material Separation
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 50948615 ↗MalfunctionSep 30, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947813 ↗MalfunctionSep 30, 2026Break
It was reported that a patient underwent an unknown procedure on an unknown date and barbed suture was used. After the first stitch passes through Apex and the fixation tape is fixed, the tape pulls and breaks instantly. No adverse patient consequences were reported. Additional information was requested.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947777 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50947350 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient underwent an unknown procedure on an unknown date and a barbed suture was used. It was stated by the ortho surgeon that they using the barbed suture in (b)(6) 2026. Post-op, the patient experienced an infection. The surgeon started to notice an uptick in infection recently and can not pin point the cause, but want to go back to using a different suture to see if it goes away. The surgeon also started using Slyke Dressing during this time. Additional information was requested.
Patient problems: Unspecified Infection
MAUDE report 50947345 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50947336 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50947333 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50947330 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient underwent an unknown procedure on an unknown date and a barbed suture was used. It was stated by the ortho surgeon that they using the barbed suture in (b)(6) 2026. Post-op, the patient experienced an infection. The surgeon started to notice an uptick in infection recently and can not pin point the cause, but want to go back to using a different suture to see if it goes away. The surgeon also started using Slyke Dressing during this time. Additional information was requested.
Patient problems: Unspecified Infection
MAUDE report 50947320 ↗
Other Ethicon, LLC products
- Coated VICRYL350 models · 8,555 reports · 1 recall
- PROLENE358 models · 7,292 reports · 2 recalls
- PDS224 models · 2,635 reports · 10 recalls
- MONOCRYL127 models · 2,308 reports · 3 recalls
- ETHILON133 models · 1,680 reports · 1 recall
- DERMABOND PRINEO4 models · 1,099 reports
- ETHIBOND EXCEL134 models · 921 reports · 2 recalls
- PERMA-HAND77 models · 664 reports · 1 recall
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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