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Zimmer Off-Axis Reamer Guide
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MEDICAL DEVICE RECALLMODERATE

Zimmer Off-Axis Reamer Guide

Zimmer recalls Off-Axis Reamer Guide (Model 110040240) due to breakage risk from catching during reaming.

What to do

Stop using the affected reamer guide immediately. Contact Zimmer, Inc. for instructions on returning the device and obtaining a replacement.

Recalled
Listed
Updated
Recall No.
Z-2528-2026
Agency
FDA
Firm
Zimmer, Inc.
Recall ID
99045
Status
ONGOING

Why it was recalled

Zimmer, Inc. is recalling the Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number 110040240, due to reports of the plastic guides catching during reaming, which can lead to breakage. Five complaints have been received.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

ProductLot codeRecall #UDI-DI
Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241110040241, 099463, 099464, 099465, 099467Z-2528-2026110040241, 00889024681941, 110040241, 00889024681941, 110040241, 00889024681941, 110040241, 00889024681941
Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040476110040476, 097492Z-2531-2026110040476, 00889024682047
Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040444110040444, 097487Z-2530-2026110040444, 00889024681903
Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number: 110040240110040240, 099457, 099458Z-2527-2026110040240, 00889024681965, 110040240, 00889024681965
Off-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040242110040242, 099471, 099473, 099474, 099475Z-2529-2026110040242, 00889024681989, 110040242, 00889024681989, 110040242, 00889024681989, 110040242, 00889024681989

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

Other Device Defect recalls

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All recalls from Zimmer, Inc.

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Editorial summary by Recall Canary · summary updated 2026-09-03 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification