Gentle Threads 905604Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00880304003255), received between Sep 1, 2021 and Sep 3, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (2 reports).

10 other recalls cover devices cleared under the same FDA submission (K041274, K982497); they may or may not involve this specific model.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2024Fracture; Fracture

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20130505 ↗
• InjurySep 1, 2021Fracture; Fracture

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 12410609 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K041274, K982497. One submission often covers many models, so check the product and lot details in each record.

• Z-3176-2018 · Jul 20, 2018 · Terminated
  Gentle Thread PLGA Round Head Interference Screw, 7x20mm, Item Number 905612
• Z-3177-2018 · Jul 20, 2018 · Terminated
  Gentle Thread PLGA Full Thread Interference Screw, 10x30mm, Item Number 905629
• Z-1738-2018 · Mar 28, 2018 · Terminated
  Gentle Threads, Interference Screw; Model No. 905608, for soft tissue reattachment procedures in the ankle/foot and knee.
• Z-1739-2018 · Mar 28, 2018 · Terminated
  Gentle Threads, Interference Screw; Model No. 905615, for soft tissue reattachment procedures in the ankle/foot and knee.
• Z-1736-2018 · Mar 28, 2018 · Terminated
  Gentle Threads, Interference Screw; Model No. 905605, for soft tissue reattachment procedures in the ankle/foot and knee.
• Z-1737-2018 · Mar 28, 2018 · Terminated
  Gentle Threads, Interference Screw; Model No. 905607, for soft tissue reattachment procedures in the ankle/foot and knee.
• Z-1734-2018 · Mar 28, 2018 · Terminated
  Gentle Threads, Interference Screw; Model No. 905617, for soft tissue reattachment procedures in the ankle/foot and knee.
• Z-1735-2018 · Mar 28, 2018 · Terminated
  Gentle Threads, Interference Screw; Model No. 905604, for soft tissue reattachment procedures in the ankle/foot and knee.
• Z-1944-2015 · Jun 3, 2015 · Terminated
  Gentle Threads Interference Screw 10x25mm Round Head. An interference fixation screw for use in soft tissue reattachment procedures.
• Z-1945-2015 · Jun 3, 2015 · Terminated
  Gentle Threads Interference Screw 9x35mm Full Thread. An interference fixation screw for use in soft tissue reattachment procedures