PDS Z443HRecalls & reported problems
Ethicon Inc. · Clear Monofilament (Polydioxanone), Absorbable Surgical Suture · Class 2 · Implant
All models of PDS (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705031060999), received between May 23, 2024 and May 23, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (3 reports).
1 FDA recall record name this device's identifier, 1 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- Aug 10, 2023Class IIOpen, Classified
Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Sutures from this lot did not meet tensile strength requirement.
Z-2617-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Break3
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 23, 2024Break; Break
IT WAS REPORTED A PATIENT UNDERWENT A BREAST REDUCTION PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE BROKE. THE SURGEON WAS USING A FULL LENGTH AND TYING A KNOT WHEN IT BROKE AND THEN SHE PULLING TISSUE TOGETHER NEAR AREOLA AND IT BROKE. THERE WERE NO PATIENT CONSEQUENCES WAS REPORTED. UNKNOWN IF THE DEVICE WAS RETURNED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19380840 ↗MalfunctionMay 23, 2024Break; Material Separation; Break; Material Separation
IT WAS REPORTED A PATIENT UNDERWENT A BREAST REDUCTION PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE BROKE AND THE SUTURE POPPED OFF AT THE NEEDLE THE SURGEON WAS USING A FULL LENGTH AND TYING A KNOT WHEN IT BROKE AND THEN SHE PULLING TISSUE TOGETHER NEAR AREOLA AND IT BROKE. THERE WERE NO PATIENT CONSEQUENCES WAS REPORTED. UNKNOWN IF THE DEVICE WAS RETURNED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19380837 ↗MalfunctionMay 23, 2024Break; Break
IT WAS REPORTED A PATIENT UNDERWENT A BREAST REDUCTION PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE BROKE AND TYING A KNOT WHEN IT BROKE AND THEN SHE PULLING TISSUE TOGETHER NEAR AREOLA AND IT BROKE. THERE WERE NO PATIENT CONSEQUENCES WAS REPORTED. UNKNOWN IF THE DEVICE WAS RETURNED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19380836 ↗
Other SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE devices
- STRATAFIX SXPP1A405Ethicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE617 reports
- STRATAFIX SXPP1A400Ethicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE485 reports
- STRATAFIX SXPP1A401Ethicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE446 reports
- STRATAFIX SXPP1A301Ethicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE443 reports
- STRATAFIX SXPP2B405Ethicon, LLC · Suture, surgical, absorbable, polydioxanone406 reports
- STRATAFIX SXPP1A406Ethicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE339 reports
- STRATAFIX SXPP1A404Ethicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 death319 reports
- STRATAFIX SXPP1B420Ethicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 death229 reports
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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