⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

Biomet, Inc.: Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475635 Product Description: Intramedullary Bone Saw Blade Assembly 15mm

Medical DevicesSource: FDA (device) · Date: 2026-08-12

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Biomet, Inc.
Product
Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475635 Product Description: Intramedullary Bone Saw Blade Assembly 15mm
Reason / hazard
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.
Classification
Class II
Status
Ongoing
Distribution / sold at
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.
Recall initiated
2026-07-01
Code info
UDI-DI (01)00887868507823(17)360224(10)67818769; Lot 67818769 Model No 475635; UDI-DI (01)00887868507823(17)360225(10)67818770; Lot 67818770
Product quantity
22
Voluntary mandated
Voluntary: Firm initiated
City
Warsaw
State
IN
Country
United States
Event id
99346
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