← FDA ENFORCEMENT
Z-2869-2026Class II

Biomet, Inc.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Biomet, Inc.
Product type
Device
Status
Ongoing
Report date
2026-08-12
Distribution
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.
Firm state
IN
Product quantity
26
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
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.

Product description

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

Code / lot info

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

Other recalls SPEQ maps to Environmental Monitoring
See all Environmental Monitoring recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →