Z-2869-2026 Class II Ongoing

Recalled by Biomet, Inc. — Warsaw, IN

FDA device recall Z-2869-2026 was initiated by Biomet, Inc. on July 1, 2026 and is designated Class II. Reason for recall: 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 b… The recall status is ongoing. Affected quantity: 26.

Recall Details

Product Type
Devices
Report Date
August 12, 2026
Initiation Date
July 1, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
26

Product Description

Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475630 Product Description: Intramedullary Bone Saw Blade Assembly 14mm

Reason for Recall

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.

Distribution Pattern

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.

Code Information

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