Z1™ Hip System 611201010Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887868575464), received between Oct 20, 2025 and Mar 12, 2026 — classified as 2 injuries, 1 malfunction.

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

1 other recall cover devices cleared under the same FDA submission (K233476, K251906); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A FOLLOW-UP VISIT TWO WEEKS POST-IMPLANTATION, THE PATIENT PRESENTED WITH SLOW WOULD HEALING AND WAS PRESCRIBED AN ANTIBIOTIC. AT THE NEXT FOLLOW-UP, THE ISSUE WAS RESOLVED, AND ALL COMPONENTS REMAIN IMPLANTED WITHOUT COMPLICATION. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Impaired Healing

  MAUDE report 24582050 ↗
• InjuryNov 19, 2025Positioning Failure; Fracture; Positioning Failure; Fracture

  IT WAS REPORTED THAT THE CALCAR CRACKED UPON IMPLANTATION. NO KNOWN CONSEQUENCES OR IMPACT ON THE PATIENT.

  Patient problems: Bone Fracture(s); No Clinical Signs, Symptoms or Conditions

  MAUDE report 23592429 ↗
• MalfunctionOct 20, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT DURING THE SURGERY, THE SURGEON WAS NOT COMFORTABLE WITH THE PPS COATING THICKNESS. THE STEM WAS REMOVED AND MANUALLY BROACHED AND THEN THE SURGEON REINSERTED THE STEM. MINIMAL PERCHED WAS ACHIEVED. THERE WAS NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23335378 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K233476, K251906. One submission often covers many models, so check the product and lot details in each record.

• Z-1329-2025 · Feb 12, 2025 · Open, Classified
  Z1 Femoral Hip System, Product Number 611777612