2 — Class II medical device recall Z-1823-2019
Terminated recall by Mako Surgical Corporation, reported 2019-06-26, distributed in AR, CA, FL, KS, MA, MO, NC, NJ…. The bearings of the saw attachments were ungreased.
| Recall number | Z-1823-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mako Surgical Corporation, Davie, FL, United States |
| Recall initiated | 2019-04-25 |
| Classified | 2019-06-15 |
| Reported by FDA | 2019-06-26 |
| Terminated | 2021-04-22 |
| Distributed | AR, CA, FL, KS, MA, MO, NC, NJ, NY, OH, OR, TN, TX |
| Countries outside the US | AU, CN, NL |
| Quantity | 39 |
| UPC / GTIN / UDI-DI | 00848486032128 |
| Lot numbers | 35040918 |
| Model numbers | 212480 |
Product
2.7 Degree Angled Sagittal Saw attachment (Mako Total Knee Application Only)
Reason for recall
The bearings of the saw attachments were ungreased.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1823-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.