Comprehensive 110040240Recalls & reported problems
Zimmer, Inc. · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024681965), received between Nov 4, 2025 and Jan 22, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
4 other recalls cover devices cleared under the same FDA submission (K233148, K241043); 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- May 20, 2026Open, Classified
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Z-2527-2026 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Fracture1
- Mechanical Jam1
Patient problems
- Bone Fracture(s)1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 22, 2026Mechanical Jam
IT WAS REPORTED THAT DURING SHOULDER SURGERY THE ANTERIOR PORTION OF THE GLENOID FRACTURED WHEN THE REAMER BLADE INTERACTED WITH A DISPOSABLE OFF-AXIS REAMER GUIDE. DURING INTRA-OPERATIVE REAMING, THE BLADE DUG INTO THE PLASTIC OF THE GUIDE, WHICH TORQUED THE GLENOID AND RESULTED IN AN ANTERIOR GLENOID FRACTURE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Bone Fracture(s)
MAUDE report 24152002 ↗MalfunctionNov 4, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23469483 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K233148, K241043. One submission often covers many models, so check the product and lot details in each record.
- Z-2529-2026 · May 20, 2026 · Open, ClassifiedOff-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040242
- Z-2530-2026 · May 20, 2026 · Open, ClassifiedOff-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040444
- Z-2531-2026 · May 20, 2026 · Open, ClassifiedOff-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040476
- Z-2528-2026 · May 20, 2026 · Open, ClassifiedOff-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241
Other Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented devices
- Equinoxe 320-38-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 recalls107 reports
- Equinoxe 320-42-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 recalls107 reports
- Equinoxe 320-42-03Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls87 reports
- Equinoxe 320-38-03Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls43 reports
- Equinoxe 320-42-13Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls41 reports
- Equinoxe 320-10-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented132 reports
- Equinoxe 320-36-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls27 reports
- Equinoxe 320-42-10Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls14 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.