Device product

Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 14MM- Orthopedic manual surgical instrument Item Number: 475665

Z-0595-2020

October 25, 2019

Class II

Product summary

Firm: Zimmer Biomet, Inc.
Event: Event 84224
Status: Terminated
Classification: Class II
Quantity: 34 units
Official record key: device-enforcement:Z-0595-2020

Official wording

Reason: 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

Code information: Lot Numbers: 334360, 366680, 366670 UDI: (01)00880304386587(17)280805(10)334360 (01)00880304386587(17)280530(10)366680 (01)00880304386587(17)280530(10)366670

Distribution pattern: Distribution to US states of CA, FL, IN, MN, MO, NY, and UT, Australia, and New Zealand

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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