Mako Surgical recalls 2.7 Degree Straight Sagittal Saw attachments for Total Knee and Partial Knee applications due to ungreased bearings. Affected units include specific catalog and lot numbers. Contact for remedy details.
The bearings of the saw attachments were ungreased.
Mako Surgical is recalling 2.7 Degree Straight Sagittal Saw attachments used in knee surgeries because the bearings were ungreased. This could lead to the saw becoming unstable during use, potentially causing injury to the patient or surgeon.
The bearings in the saw attachments were ungreased, which means they could become slippery or seize up during surgery. This might cause the saw to become unstable, potentially leading to injury to the patient or surgeon if it slips or moves unexpectedly.
Surgeons and medical facilities using Mako Total Knee or Partial Knee applications with the specific catalog numbers 212186 and lot numbers 35051018 or 35050918 are most at risk. These attachments are used during knee surgery procedures.
Check if your saw attachment has the catalog number 212186 and lot numbers 35051018 or 35050918. The unique device identifier (UDI) will also include these specific lot numbers.
Verify the catalog number (212186) and lot numbers (35051018 or 35050918) on your saw attachment.
The bearings in the saw attachments were ungreased, which could cause the saw to become unstable during surgery.
The recall record does not specify a remedy, so contact Mako Surgical Corporation for further instructions.
Check for catalog number 212186 and lot numbers 35051018 or 35050918 on your attachment.
We’ve drafted a message you can send Mako to request your refund or repair — edit it as you like.
Subject: Recall Z-1824-2019 — Mako Mako Hello, I own a Mako that is covered by recall Z-1824-2019 from Mako. 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.
