Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 13MM-Orthopedic manual surgical instrument Item Number: 475660
Check against the official notice below — it lists the full affected range.
Zimmer Biomet, Inc. is recalling 26 units of its Biomet Orthopedics Intramedullary Bone Saw Cam Assembly (13MM), Item Number 475660, due to a labeling and measurement mismatch. Some units labeled and etched as 14 MM assemblies actually measured as 13 MM cams, creating a risk of confusion between the two sizes. The affected devices were distributed to California, Florida, Indiana, Minnesota, Missouri, New York, and Utah, as well as Australia and New Zealand, across three lot numbers: 025800, 025810, and 081640.
The product recall record does not specify a remedy or recommended action for affected consumers or healthcare facilities.
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: 26 units Lot/code info: Lot Numbers: 025800, 025810, 081640 UDI: (01)00880304386570(17)280202(10)025800 (01)00880304386570(17)280205(10)025810 (01)00880304386570(17)280524(10)081640
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.