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.
Possible hinge pin disassociation from the Mako Onlay Insert Extractor.
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.
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.
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.
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.
If you have the Restoris MCK Onlay Insert Extractor with the listed lot numbers, stop using it right away.
The hinge pin may disassociate from the Mako Onlay Insert Extractor, causing it to malfunction during surgical procedures.
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).
The recall does not specify a return process, but you should stop using it immediately and contact the manufacturer for further instructions.
We’ve drafted a message you can send Mako Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-2051-2018 — Mako Surgical Mako Surgical Hello, I own a Mako Surgical that is covered by recall Z-2051-2018 from Mako Surgical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
