FDAClass IIJune 26, 2019

2.7 Degree Angled Sagittal Saw attachment recall

2.7 Degree Angled Sagittal Saw attachment (Mako Total Knee Application Only)

Why was 2.7 Degree Angled Sagittal Saw attachment recalled?

The bearings of the saw attachments were ungreased.

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?

Catalog Number: 212480 Lot Number: 35040918 UDI: (01)00848486032128(10)35040918

Product
2.7 Degree Angled Sagittal Saw attachment (Mako Total Knee Application Only)
Recalling firm
Mako Surgical Corporation
Quantity
39
Distribution
AR, CA, FL, KS, MA, MO, NC, NJ, NY, OH, OR, TN, and TX. Australia, China and Netherlands
Recall date
June 26, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls