NA 72203896Recalls & reported problems
Smith & Nephew, Inc. · ULTRATAPE 2MM BLUE 38 PKG OF 6 · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885554031638), received between Apr 29, 2019 and Feb 27, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Break1
- Detachment of Device or Device Component1
Patient problems
- Device Embedded In Tissue or Plaque1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 27, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT, DURING A BROSTRÖM ANKLE LIGAMENT REPAIR FOLLOWING PROPER IMPLANT PLACEMENT, THE ULTRATAPE 2MM BLUE 38 PKG OF 6 DISENGAGED DESPITE ADHERENCE TO THE ESTABLISHED TECHNIQUE. THE MICRORAPTOR KNOTLESS SA PEEK WAS LEFT INSIDE THE PATIENT. THE INSERTION SITE WAS CLEARED OF ALL DEBRIS PRIOR TO INSERTION. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 24472236 ↗MalfunctionApr 29, 2019Break
IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION PROCEDURE, WHEN LINKING THE ACL GRAFT AND SUTURE BUTTON, THE ULTRATAPE SUTURE BROKE. THE SUTURE WAS REMOVED FROM THE BODY. A BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH EXTENDED SURGICAL TIME OF 15 MIN. THE PATIENT WAS NOT INJURED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8561137 ↗
Other SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE devices
- FAST-FIX 72202468Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 death6,626 reports
- FAST-FIX 72201491Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE863 reports
- FAST-FIX 72202469Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE561 reports
- FAST-FIX 72205676Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE439 reports
- Arthrex® AR-4501Arthrex, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE403 reports
- FAST-FIX 72205324Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE383 reports
- LUPINE ORTHOCORD 210712Medos International Sàrl · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE357 reports
- FAST-FIX 72201494Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE249 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 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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