Z1™ Hip System 611201060Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887868575518), received between Oct 15, 2025 and May 8, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 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.

• MalfunctionMay 8, 2026Positioning Failure; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SURGEON BROACHED THE RIGHT FEMUR TO A SIZE 6 AND THE BROACH WAS TIGHT. THE SIZE 6 STEM WAS THEN LOOSE. STEM WAS NOT USED. 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 25123433 ↗
• MalfunctionOct 15, 2025Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THE FINAL STEM IMPLANTATION PERCHED A COUPLE MILLIMETERS. THE SURGEON NOTED THAT THE PPS COATING IS THICK AND NEEDS TO BE REDUCED TO ALLOW ACCURATE 1:1 BROACH TO STEM. NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23292732 ↗

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