Gentle Threads 905608Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00880304006676), received between Jun 25, 2021 and Jan 18, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD STIFFNESS AND LIMITED RANGE OF MOTION THREE WEEKS POST-SURGERY. THE PATIENT UNDERWENT MOBILIZATION UNDER GENERAL ANESTHESIA. SIX MONTHS POST-SURGERY, THE PATIENT HAD FULL RECOVERY OF ROM. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Loss of Range of Motion

  MAUDE report 16195617 ↗
• InjuryJan 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT AN ANTERIOR FIBROSIS RESECTION THREE MONTHS POST IMPLANTATION DUE TO CYCLOPS SYNDROME. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Adhesion(s); Scar Tissue

  MAUDE report 16138334 ↗
• MalfunctionJun 25, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE INTERFERENCE SCREW WAS BROKEN WHILE FIXING. ATTEMPTS HAVE BEEN MADE, BUT NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12068819 ↗

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-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-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-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-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-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-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