Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 14MM- Orthopedic manual surgical instrument Item Number: 475665
Check against the official notice below — it lists the full affected range.
Zimmer Biomet is recalling 34 units of Biomet Orthopedics Intramedullary Bone Saw Cam Assembly (Item Number 475665) used in orthopedic manual surgical procedures. The recalled units are labeled and etched as 14 MM but actually measure as 13 MM components, creating a possible mix-up between the two different sizes. The affected products were distributed to California, Florida, Indiana, Minnesota, Missouri, New York, and Utah, as well as to Australia and New Zealand, with lot numbers 334360, 366680, and 366670.
The source document does not specify a remedy for affected consumers or provide instructions on what actions should be taken regarding the recalled product.
Written by software from the official notice below. Not reviewed by a lawyer.
Possible commingle of 13 MM and 14 MM Intramedullary Bone Saw Cam Assembly -an Intramedullary Bone Saw Cam Assembly was labeled and etched as a 14 MM but measured as a 13 MM cam
Reason for recall: Possible commingle of 13 MM and 14 MM Intramedullary Bone Saw Cam Assembly -an Intramedullary Bone Saw Cam Assembly was labeled and etched as a 14 MM but measured as a 13 MM cam Distribution: Distribution to US states of CA, FL, IN, MN, MO, NY, and UT, Australia, and New Zealand Quantity: 34 units Lot/code info: Lot Numbers: 334360, 366680, 366670 UDI: (01)00880304386587(17)280805(10)334360 (01)00880304386587(17)280530(10)366680 (01)00880304386587(17)280530(10)366670
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.