Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-1823-2019

April 25, 2019

Class II

Product summary

Firm
Mako Surgical Corporation
Event
Event 82738
Status
Terminated
Classification
Class II
Quantity
39
Official record key
device-enforcement:Z-1823-2019

Official wording

Reason: The bearings of the saw attachments were ungreased.

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

Distribution pattern: AR, CA, FL, KS, MA, MO, NC, NJ, NY, OH, OR, TN, and TX. Australia, China and Netherlands

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The bearings of the saw attachments were ungreased.