RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee… — Class II medical device recall Z-1644-2018
Terminated recall by Mako Surgical Corporation, reported 2018-05-16, distributed in AL, AR, AZ, CA, CO, FL, GA, HI…. Incorrect product and/or label. Sizing is labeled incorrectly.
| Recall number | Z-1644-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mako Surgical Corporation, Davie, FL, United States |
| Recall initiated | 2017-12-01 |
| Classified | 2018-05-04 |
| Reported by FDA | 2018-05-16 |
| Terminated | 2020-12-14 |
| Distributed | AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, LA, MA, MD, MI, MN, NC, NE, NH, NJ, NY, OK, OR, PA, RI, SC, TX, UT, VA, WA, WY |
| Countries outside the US | AU, GB, IT, KR, NL, SG, VN |
| Quantity | 126 |
| Reason classes | labeling |
| Lot numbers | 26080317-01, 26150217-01 |
| Model numbers | 180612, 180617 |
Product
RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements.
Reason for recall
Incorrect product and/or label. Sizing is labeled incorrectly.
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-1644-2018. 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.