EpiFIX PK-EFC0222TRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI B562PKEFC0222T0), received between Sep 12, 2020 and Sep 12, 2020 — classified as 1 malfunction.

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

1 other recall cover devices cleared under the same FDA submission (K182704); 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. How this data works · Data updated Oct 13, 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.

• MalfunctionSep 12, 2020Fracture; Fracture

  IT WAS REPORTED THAT SCREWS PULLED THROUGH 3 OF THE EPIFIX PLATES DURING SURGERY. IT WAS REPORTED THAT THIS DID NOT AFFECT THE OUTCOME OF THE SURGERY ON THE PATIENT. NO INJURY OR DELAY OF SURGERY WAS REPORTED. 3 PLATES WERE EXPLANTED, REMAINING 4 PLATES WERE IMPLANTED SUCCESSFULLY. NO ALLEGATIONS WERE REPORTED AGAINST THE SCREWS OR INSTRUMENTS IN THE PROCEDURAL KITS. THIS IS DEVICE 2 OF 3 (SEE 3013680140-2020-00001 & 3013680140-2020-00003 FOR REMAINING DEVICES). DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10526087 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K182704. One submission often covers many models, so check the product and lot details in each record.

• Z-1808-2024 · Apr 5, 2024 · Open, Classified
  WishFIX Growth Control Plating System, Model Number: TEFCS28-080US. Orthopedic device.