FDA Device recall Z-2051-2018
Restoris MCK Onlay Insert Extractor
- FDA Device
- Class II
- terminated
- Published 2018-06-13
On 2018-06-13 the FDA classified a Class II recall of Restoris MCK Onlay Insert Extractor by Mako Surgical, citing possible hinge pin disassociation from the Mako Onlay Insert Extractor.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2051-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-01-19 |
| Published | 2018-06-13 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Mako Surgical |
| Distribution | 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 |
Product
Restoris MCK Onlay Insert Extractor.
Reason
Possible hinge pin disassociation from the Mako Onlay Insert Extractor.
Identifiers
| code_info | Item No. 160430, Lot No. 19020414, 19090616, 19090915, 19100616, 19100915, 19110317, 19110616, 19110915, 19130315, 1914…Item No. 160430, Lot No. 19020414, 19090616, 19090915, 19100616, 19100915, 19110317, 19110616, 19110915, 19130315, 19140315, 19451016, 19461016, 19471016, 19490515, 19500515, 19510515, 19520515, 19530515, 26051212, 26070512, 26080913, 26110512, 26120512, 26130512, 26170513, 26201111, 26290412, 26330712, 26340312, 26440912. Expanded scope: Lot No. 19150517, 19160517. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2051-2018%22
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