Omnifit 6017-0935ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327038279), received between Jun 6, 2023 and Jun 8, 2023 — classified as 2 injuries.

1 other recall cover devices cleared under the same FDA submission (K913812, K982032); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PI IS FOR THE FEMORAL STEM AND HEAD. IT WAS REPORTED THAT THE PATIENT'S RIGHT FEMUR WAS REVISED. AFTER A PREVIOUS ORIF TO ADDRESS A FEMORAL FRACTURE, PATIENT PRESENTED COMPLAINING OF PAIN AND LIMITED ROM. X-RAY SHOWED NON-UNION OF THE BONE WITH 3 BROKEN SCREWS AND ONE SCREW WHICH PULLED OUT WITH THE PLATE. A FEMORAL STEM AND HEAD, THE PLATE AND SCREWS, AND A COMPETITOR KNEE WERE REVISED TO A COMPETITOR TOTAL FEMUR REPLACEMENT (ACETABULAR COMPONENTS WERE LEFT IN SITU). REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Bone Fracture(s); Loss of Range of Motion; Pain

  MAUDE report 17084996 ↗
• InjuryJun 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER IMPLANTATION OF A RIGHT STRYKER HIP AND COMPETITOR KNEE, THE PATIENT FELL AND SUSTAINED A FEMORAL FRACTURE NEAR THE DISTAL TIP OF THE STEM. NO IMPLANTS WERE REVISED, BUT AN ORIF WAS PERFORMED WITH IMPLANTATION OF A PLATE AND SCREWS. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 17076308 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K913812, K982032. One submission often covers many models, so check the product and lot details in each record.

• Z-0891-2009 · Nov 13, 2008 · Terminated
  Omnifit HA Hip Stem These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or