Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241
Summary
The FDA issued a Class II for Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide by Zimmer, Inc.. Reason: Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage..
Details
Source
Device Recall
External ID
Z-2528-2026
Action Date
2026-07-01
Status
Ongoing
Category
device
Product Description
Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241
Lot/Code Info: Lot Code: Model No. 110040241 ; UDI-DI (01)00889024681941(17)350602(10)099463 ; Lot Number 099463 Model No. 110040241 ; UDI-DI (01)00889024681941(17)350531(10)099464 ; Lot Number 099464 Model No. 110040241 ; UDI-DI (01)00889024681941(17)350812(10)099465 ; Lot Number 099465 Model No. 110040241 ; UDI-DI (01)00889024681941(17)350707(10)099467 ; Lot Number 099467
Quantity Affected: 435 units
Reason for Recall
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-05-20
Company
Warsaw, IN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 286 device recalls issued in the same week, part of 534 device-related FDA actions this month.
Zimmer, Inc. has 94 FDA actions in our database, including 71 recalls and 23 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Zimmer, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Zimmer, Inc. have FDA actions?
Zimmer, Inc. has 94 FDA actions in our database, including 71 recalls and 23 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2528-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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