FDA-Device2026-07-01Class IIPROCESSING DEFECT
Zimmer Off-Axis Alliance Glenoid Reamer Guide recalled for breakage during surgery
What this means
Zimmer, Inc. is recalling a surgical guide used during shoulder implant procedures. Five reports have identified that the plastic guide can catch and break during the reaming step of surgery, potentially affecting the procedure.
- If you received this device (Lot 097487), contact Zimmer, Inc. immediately for instructions
- Do not use this device if you have it in inventory
- Report any breakage or procedure complications to your device supplier or Zimmer
The agency's original wording
Hazard
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
11 units
Manufactured in
1800 W Center St, N/A, Warsaw, IN, United States
Products
Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040444
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2530-2026Want us to check the next one for you?
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