Z1™ Hip System 611201020Recalls & reported problems
Zimmer, Inc. · Class 2 · Implant
All models of Z1 Hip System (17)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887868575471), received between Oct 20, 2025 and May 27, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Difficult to Insert” (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.
Reports received per month
Most reported problems
Device problems
- Difficult to Insert1
- Nonstandard Device1
- Positioning Failure1
- Product Quality Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 27, 2026Positioning Failure; Nonstandard Device
IT WAS REPORTED THAT DURING A RIGHT HIP PROCEDURE, THE FEMUR WAS BROACHED TO A SIZE 2 AND THE SIZE 2 STEM IMPLANT WENT RIGHT INTO THE FEMUR BY HAND WITHOUT IMPACTION. THE SURGEON DID NOT WANT TO BROACH UP BIGGER SO OPENED A SECOND STEM OF THE SAME SIZE. THE SECOND STEM SEATED APPROPRIATELY AND WAS IMPACTED WITH GREAT RESULT. 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 25310900 ↗MalfunctionOct 20, 2025Difficult to Insert; Product Quality Problem; Difficult to Insert; Product Quality Problem
IT WAS REPORTED THAT DURING A LEFT HIP PROCEDURE, THE STEM COULD NOT BE FULLY SEATED AND THE STEM SAT PERCHED AFTER IMPLANTATION. SURGEON BELIEVES THE COATING ON THE STEM IS TOO THICK. THERE WAS NO ADDITIONAL BROACHING CONDUCTED. THE STEM WAS IMPLANTED WITH NO FURTHER INTERVENTION MADE. 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 23335458 ↗
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, ClassifiedZ1 Femoral Hip System, Product Number 611777612
Other Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented devices
- STAGEONE 431209Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented2 recalls0 reports
- SELF CENTERING 1035-45-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented84 reports
- LFIT 6260-9-036Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented80 reports
- ACTIS 101011060Depuy (Ireland) · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented66 reports
- RINGLOC BI-POLAR HIP SYSTEM 11-165228Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall1 death12 reports
- SELF CENTERING 1035-44-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented60 reports
- TANDEM 71324046Smith & Nephew, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall9 reports
- TAPERLOC COMPLETE XR 123 MICRO FEMORAL 51-145170Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented59 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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