RecallRadar

FDA Device recall Z-1823-2019

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

On 2019-06-26 the FDA classified a Class II recall of 2.7 Degree Angled Sagittal Saw attachment (Mako Total Knee Application Only) by Mako Surgical, citing the bearings of the saw attachments were ungreased.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1823-2019
ClassificationClass II
Statusterminated
Initiated2019-04-25
Published2019-06-26
Last updated2026-09-13 11:55 UTC
CompanyMako Surgical
DistributionAR, CA, FL, KS, MA, MO, NC, NJ, NY, OH, OR, TN, TX

Product

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

Reason

The bearings of the saw attachments were ungreased.

Identifiers

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1823-2019%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.