FDAClass IIDecember 11, 2019

Biomet Orthopedics Intramedullary Bone Saw Cam Assembly recall

Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 13MM-Orthopedic manual surgical instrument Item Number: 475660

Why was Biomet Orthopedics Intramedullary Bone Saw Cam Assembly recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Numbers: 025800, 025810, 081640 UDI: (01)00880304386570(17)280202(10)025800 (01)00880304386570(17)280205(10)025810 (01)00880304386570(17)280524(10)081640

Product
Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 13MM-Orthopedic manual surgical instrument Item Number: 475660
Recalling firm
Zimmer Biomet, Inc.
Quantity
26 units
Distribution
Distribution to US states of CA, FL, IN, MN, MO, NY, and UT, Australia, and New Zealand
Recall date
December 11, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls