FDA Device recall Z-1824-2019
2.7 Degree Straight Sagittal Saw attachment (Mako Total Knee Application and Partial Knee Application 3.0)
- FDA Device
- Class II
- terminated
- Published 2019-06-26
On 2019-06-26 the FDA classified a Class II recall of 2.7 Degree Straight Sagittal Saw attachment (Mako Total Knee Application and Partial Knee Application 3.0) by Mako Surgical, citing the bearings of the saw attachments were ungreased.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1824-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-04-25 |
| Published | 2019-06-26 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Mako Surgical |
| Distribution | AR, CA, FL, KS, MA, MO, NC, NJ, NY, OH, OR, TN, TX |
Product
2.7 Degree Straight Sagittal Saw attachment (Mako Total Knee Application and Partial Knee Application 3.0)
Reason
The bearings of the saw attachments were ungreased.
Identifiers
| code_info | Catalog Number: 212186 Lot Number: 35051018 and 35050918 UDI: (01)00848486032111(10)35051018 and (01)00848486032111(10)35050918 |
|---|
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-1824-2019%22
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