NA 9026-29Recalls & reported problems
Zimmer, Inc. · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024156081), received between Jun 13, 2023 and Jun 13, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).
4 other recalls cover devices cleared under the same FDA submission (K960278); 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
Device problems
- Device Dislodged or Dislocated1
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 13, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: Failure of Implant
MAUDE report 17119104 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K960278. One submission often covers many models, so check the product and lot details in each record.
- Z-1162-2016 · Jan 11, 2016 · TerminatedProduct 64 consists of all product under product code: JDI and same usage: Item no: 902605101 UNIPOLAR ENDO FEM HEAD 51MM For use in hemi hip arthroplasty
- Z-1109-2016 · Jan 11, 2016 · TerminatedProduct 11 consists of all product under product code JDI , and same usage: Item no: 902602500 6 DEGREE COCR FEM HEAD 26 902602600 6 DEGREE COCR FEM HEAD 26 902602700 6 DEGREE COC
- Z-2548-2014 · Jul 22, 2014 · TerminatedEndo & Unipolar Femoral Heads: ENDO FEMORAL HEAD 43MM DIA, ENDO FEMORAL HEAD 53MM DIA, ENDO FEMORAL HEAD 47MM DIA, ENDO FEMORAL HEAD 50MM DIA, ENDO FEMORAL HEAD 42MM DIA, ENDO FEMO
- Z-1033-2014 · Oct 11, 2013 · Terminated6 DEGREE COCR FEM HEAD (various sizes) and 6 DEG UNIPOLAR FEMORAL HE
Other Prosthesis, hip, semi-constrained, metal/polymer, cemented devices
- NA 1365-51-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented753 reports
- NA 1365-50-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented412 reports
- ARTICUL/EZE 1365-21-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall280 reports
- ARTICUL/EZE 1365-11-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 death262 reports
- LFIT 6260-9-236Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, cemented256 reports
- PINNACLE GRIPTION 1217-32-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented2 deaths239 reports
- ELEOS™ 25002111EOnkos Surgical, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented3 deaths230 reports
- Novation 130-36-52Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls124 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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