Mako Restoris Onlay Insert Extractor Recall: Possible hinge pin disassociation
Mako Surgical recalls Restoris MCK Onlay Insert Extractor with possible hinge pin disassociation. Affected items include specific lot numbers from 2019-2023. Stop using immediately if you own this surgical device.
Stop using this now
Possible hinge pin disassociation from the Mako Onlay Insert Extractor.
Contact the company
What happened, in plain English
Mako Surgical is recalling their Restoris MCK Onlay Insert Extractor due to a risk of the hinge pin separating. This could cause the device to malfunction during surgical procedures, potentially leading to injury or complications for patients. Read more at govinfonow.com/recall/72122-mako-restoris-onlay-insert-extractor-recall-possible-hinge-pin-disassociation.
Source Summary by GovInfoNow · govinfonow.com/recall/72122-mako-restoris-onlay-insert-extractor-recall-possible-hinge-pin-disassociation · Updated August 31, 2026 · FDA enforcement record: FDA #Z-2051-2018
Cite this page
“Mako Restoris Onlay Insert Extractor Recall: Possible hinge pin disassociation.” GovInfoNow, updated August 31, 2026. https://govinfonow.com/recall/72122-mako-restoris-onlay-insert-extractor-recall-possible-hinge-pin-disassociation. Based on FDA recall #Z-2051-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2051-2018%22&limit=1).
Why it’s dangerous
The hinge pin in the device may become disassociated, causing the surgical tool to detach during use. This could lead to the device malfunctioning or causing injury to the patient or the surgeon.
Who’s affected
Surgical professionals who use the Restoris MCK Onlay Insert Extractor are affected. Those who have the device with the listed lot numbers are most at risk.
How to tell if you have this one
Check the lot number on the device, which is listed in the specific dates and numbers provided in the recall notice. The affected items were sold between 2019 and 2023 with the listed lot numbers.
- Brand
Mako Surgical- Category
Medical device
What to do — step by step
Stop Using Immediately
If you have the Restoris MCK Onlay Insert Extractor with the listed lot numbers, stop using it right away.
Where it went and when
Where it was distributed
Distributed in 29 states, and outside the U.S.
FDA distribution: “Distributed domestically to 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. Distributed internationally to Australia, China, Italy, Netherlands, Singapore, South Africa,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Illinois, Indiana, Kansas, Louisiana, Maryland, Michigan, Minnesota, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Wisconsin.
Recall timeline
FDA terminated this recall 2.7 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Which lot numbers are affected?
Affected lot numbers include 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, and 19150517, 19160517 (expanded scope).
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2051-2018 (January 19, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2051-2018 to see it in context.
- Plain-language summary written by qwen3:4b on August 31, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.