Speed Titan SE-1815TIRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00810633021521), received between Jun 21, 2022 and Feb 19, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Inaccurate Information” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SURGEON HAD TO REMOVE THE STAPLES FROM 5 OF 10 OTHER PATIENTS BECAUSE OF A REACTION. HE BELIEVES IT'S NOT AN INFECTION DISEASE CONCERN BUT MORE WITH THE CONTENT OF NICKEL GOING FROM A LIGHT GRAY IN COLOR TO A DARK GRAY IN COLOR. PATIENT OUTCOME IS REPORTED AS DOING WELL WITHOUT PROBLEMS. FINDINGS: ARTHRITIC BONE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 21414731 ↗
• MalfunctionNov 10, 2023Inaccurate Information; Inaccurate Information

  IT WAS REPORTED THAT ON (B)(6) 2023 WHILE CONDUCTING AUDITS, ITEMS LABELED A SPECIFIC ITEM NUMBER WERE LABELED DIFFERENTLY ON THE BACK OF THE BOX. THE BARCODE NUMBER APPEARS AS A DIFFERENT ITEM. NO SURGICAL DELAY. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A SPEEDTITAN COMPRESSION IMPL KIT 18X15X15 THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18116914 ↗
• MalfunctionOct 16, 2023Inaccurate Information; Inaccurate Information

  IT WAS REPORTED THAT ON (B)(6) 2023 WHILE CONDUCTING AUDITS, IT WAS DISCOVERED THAT THE ITEM IN QUESTION LABELED WITH A SPECIFIC ITEM NUMBER WAS LABELED DIFFERENTLY ON THE BACK OF THE BOX. THE BARCODE NUMBER APPEARS AS A DIFFERENT ITEM. THERE WAS NO REPORTED PROCEDURE OR PATIENT INVOLVEMENT. THIS REPORT IS FOR A SPEED TITAN 18X15X15MM IMPLANT KIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17940356 ↗
• MalfunctionJun 21, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE DOCTOR WAS OPERATING ON A PATIENT THAT PRESENTED WITH A LISFRANC FRACTURE. THE SURGEON REQUESTED AN SE-1815TI BME STAPLE, BUT THE BIN ONLY HAD BOXES OF SE 181815TI STAPLES AVAILABLE. UPON FURTHER INSPECTION, IT WAS DISCOVERED THAT TWO OF THE BOXES OF SE 181815TI STAPLES ACTUALLY CONTAINED SE-1815TI STAPLES INSIDE OF THE IMPLANT BOX. THE GREY OUTER BOX SHOWS SE-181815TI, BUT THE IMPLANT STICKER WITH BARCODE READS SE-1815TI. ONE OF THE IMPLANTS WAS OPENED AND IT WAS SUCCESSFULLY IMPLANTED WITH NO ADVERSE EVENT TO THE PATIENT. THIS REPORT IS FOR A SPEED TITAN 18X15X15MM IMPLANT KIT. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14754394 ↗
• MalfunctionJun 21, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE DOCTOR WAS OPERATING ON A PATIENT THAT PRESENTED WITH A LISFRANC FRACTURE. THE SURGEON REQUESTED AN SE-1815TI BME STAPLE, BUT THE BIN ONLY HAD BOXES OF SE 181815TI STAPLES AVAILABLE. UPON FURTHER INSPECTION, IT WAS DISCOVERED THAT TWO OF THE BOXES OF SE 181815TI STAPLES ACTUALLY CONTAINED SE-1815TI STAPLES INSIDE OF THE IMPLANT BOX. THE GREY OUTER BOX SHOWS SE-181815TI, BUT THE IMPLANT STICKER WITH BARCODE READS SE-1815TI. ONE OF THE IMPLANTS WAS OPENED AND IT WAS SUCCESSFULLY IMPLANTED WITH NO ADVERSE EVENT TO THE PATIENT. THIS REPORT IS FOR A SPEED TITAN 18X15X15MM IMPLANT KIT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14754376 ↗