FUZE FZ120-200T-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00841731107275), received between Dec 27, 2018 and Dec 27, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Osseointegrate” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K102413); 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 18, 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.

• MalfunctionDec 27, 2018Failure to Osseointegrate; Failure to Osseointegrate

  FUZE NAIL BROKE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8201210 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K102413. One submission often covers many models, so check the product and lot details in each record.

• Z-1723-2015 · Apr 22, 2015 · Terminated
  Vilex, Inc., FUZE 10.0 mm x 250 mm, Product # FZ100-250T-25. Ankle arthrodesis, tibio-talo-calcaneal arthrodesis.
• Z-1722-2015 · Apr 22, 2015 · Terminated
  Vilex, Inc., FUZE 10.0 mm x 200 mm, Product # FZ100-200T-25. Ankle arthrodesis, tibio-talo-calcaneal arthrodesis.
• Z-1721-2015 · Apr 22, 2015 · Terminated
  Vilex, Inc., FUZE 10.0 mm x 150 mm, Product # FZ100-150T-25. Ankle arthrodesis, tibio-talo-calcaneal arthrodesis.