Restoris MCK Onlay Insert Extractor — Class II medical device recall Z-2051-2018
Terminated recall by Mako Surgical Corporation, reported 2018-06-13, distributed in AL, AR, AZ, CA, CO, CT, FL, IL…. Possible hinge pin disassociation from the Mako Onlay Insert Extractor.
| Recall number | Z-2051-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mako Surgical Corporation, Davie, FL, United States |
| Recall initiated | 2018-01-19 |
| Classified | 2018-06-01 |
| Reported by FDA | 2018-06-13 |
| Terminated | 2020-09-16 |
| Distributed | AL, AR, AZ, CA, CO, CT, FL, IL, IN, KS, LA, MD, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, TN, TX, UT, WI |
| Countries outside the US | AU, CN, GB, IT, NL, SG, TR, TW, ZA |
| Lot numbers | 19020414, 19090616, 19090915, 19100616, 19100915, 19110317, 19110616, 19110915, 19130315, 19140315, 19150517, 19160517, 19451016, 19461016, 19471016, 19490515, 19500515, 19510515, 19520515, 19530515, 26051212, 26070512, 26080913, 26110512, 26120512, 26130512, 26170513, 26201111, 26290412, 26330712, 26340312, 26440912 |
| Model numbers | 160430 |
Product
Restoris MCK Onlay Insert Extractor.
Reason for recall
Possible hinge pin disassociation from the Mako Onlay Insert Extractor.
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-2051-2018. 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.