Reported Jul 1, 2026 · Ongoing
Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241
Zimmer, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zimmer, Inc. · 1800 W Center St · Warsaw, IN · 46580-2304
Is this the product you have?
- Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis
- Reamer Guide Model/Catalog Number110040241
- Lot codes and dates
9 of 9 products
Products covered by this recall Model / number Barcodes Product as published 110040241Lot Code — 00889024681941UDI-DI (01)00889024681941(17)350602(10)099463 110040241Lot Number 099463 — 00889024681941UDI-DI (01)00889024681941(17)350531(10)099464 110040241Lot Number 099464 — 00889024681941UDI-DI (01)00889024681941(17)350812(10)099465 110040241Lot Number 099465 — 00889024681941UDI-DI (01)00889024681941(17)350707(10)099467 — Lot Number 099467 - Amount recalled
- 435 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
Why it was recalled
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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