SOFTSILK 7207259Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010375391), received between Mar 18, 2020 and Mar 18, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

1 other recall cover devices cleared under the same FDA submission (K921481); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING AN ACL REVISION SURGERY, A NEW 8X20MM SOFTSILK SCREW WAS USED, BUT THE TENDON WAS LOOSE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP 8X10MM SOFTSILK SCREW INTO AN ADDITIONAL BONE HOLE. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9848772 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K921481. One submission often covers many models, so check the product and lot details in each record.

• Z-1510-2021 · Apr 8, 2021 · Terminated
  CANNU-Flex SILK Interference Screws 6 mmx 30 mm - Product Usage: used for interference fixation of bone-tendon-bone of soft tissue grafts in anterior cruciate ligament reconstructi