United StatesIntramedullary Bone Saw Blade Assemblies (models/catalog numbers 475620, 475625, 475630, 475635, 475640; sizes 12 mm–16 mm) are affected, with specific UDI-DIs and lot numbers listed in the recall notice. The devices were recalled because of potential sterile barrier packaging damage caused by an exposed saw blade.
What's being recalled
Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475620 Product Description: Intramedullary Bone Saw Blade Assembly 12mm
Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475625 Product Description: Intramedullary Bone Saw Blade Assembly 13mm
Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475630 Product Description: Intramedullary Bone Saw Blade Assembly 14mm
Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475635 Product Description: Intramedullary Bone Saw Blade Assembly 15mm
Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475640 Product Description: Intramedullary Bone Saw Blade Assembly 16mm
Recalling firm: Biomet, Inc., Warsaw, IN, United States.
How to identify it
UDI-DI (01)00887868507793(17)360407(10)67818791; Lot 67818791 UDI-DI (01)00887868507809(17)360228(10)67818772; Lot 67818772 UDI-DI (01)00887868507816(17)360221(10)67818764; Lot 67818764 Model No 475630; UDI-DI (01)00887868507816(17)360401(10)67818768; Lot 67818768 Model No 475630; UDI-DI (01)00887868507816(17)360428(10)67954534; Lot 67954534 UDI-DI (01)00887868507823(17)360224(10)67818769; Lot 67818769 Model No 475635; UDI-DI (01)00887868507823(17)360225(10)67818770; Lot 67818770 UDI-DI (01)00887868507830(17)360316(10)67818792; Lot 67818792
The 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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
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.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)