ALLTHREAD KNOTLESS PEEK-OPTIMA 904843PRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00880304470934), received between Oct 15, 2019 and Oct 15, 2019 — classified as 1 malfunction.

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

1 other recall cover devices cleared under the same FDA submission (K070389); 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.

• MalfunctionOct 15, 2019Packaging Problem; Packaging Problem

  IT WAS REPORTED DURING THE DISTRIBUTION PROCESS PACKAGING DAMAGE WITH STERILITY BARRIER POTENTIALLY COMPROMISED WAS IDENTIFIED. NO PATIENT OR SURGICAL INVOLVEMENT. NO FURTHER INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: No Patient Involvement

  MAUDE report 9191381 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K070389. One submission often covers many models, so check the product and lot details in each record.

• Z-0191-2010 · Sep 9, 2009 · Terminated
  Biomet 5.5 mm peek Allthread PEEK Knotless Anchor, knotless, sterile, Biomet sports Medicine, Inc., Ontario, CA; REF 904842P. Intended to be implanted for fixation of bone fractur