Recall Ledger

Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475620 Product... recall (Biomet, Inc.)

Medical deviceClass IIOngoing

Summary: Biomet, Inc. is recalling Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475620 Product Description: Intramedullary Bone Saw Blade Assembly 12mm. Reason: Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.

What is being recalled

Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475620 Product Description: Intramedullary Bone Saw Blade Assembly 12mm

Why

Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

Refer to the attached ZFA 2026-00096_Initial Consignee List and ZFA 2026-00096_Initial Distribution History containing the distribution and the identification of the affected consignees.

How to tell if yours is affected

UDI-DI (01)00887868507793(17)360407(10)67818791; Lot 67818791

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

Recall numberZ-2867-2026
CategoryMedical device
AgencyU.S. Food and Drug Administration (FDA)
SeverityClass II
StatusOngoing
Recall startedJuly 1, 2026
ReportedAugust 12, 2026
CompanyBiomet, Inc.
Company locationWarsaw, IN, United States
Initiated byVoluntary: Firm initiated
Quantity10

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Official FDA record