Mako Surgical recalls Rio System Irrigation Clip (Catalog #111690) for out of tolerance risk in RESTORIS Partial Knee Application procedures. Affected lots include 176364, 178346, 181337, 185213, 186561, 189709, 190559, 193643, and 195763A1.
Out of tolerance.
Mako Surgical is recalling the Rio System Irrigation Clip (Catalog #111690) used with RESTORIS Partial Knee Application procedures. The recall is due to a risk of being out of tolerance, which could affect surgical accuracy during knee procedures. This is a critical safety issue for surgeons using the device.
The clip is designed to assist surgeons in providing software-defined spatial boundaries during orthopedic procedures. Being out of tolerance could lead to inaccurate surgical reference points, potentially causing errors in knee replacements.
Surgeons using the Rio System Irrigation Clip with RESTORIS Partial Knee Application procedures are affected. The most at-risk users are those operating on patients with unicondylar or patellofemoral knee replacements.
Check for the Rio System Irrigation Clip with Catalog #111690 used in RESTORIS Partial Knee Application procedures. Affected lots include 176364, 178346, 181337, 185213, 186561, 189709, 190559, 193643, and 195763A1.
Identify the lot number on the Rio System Irrigation Clip to see if it matches the affected lots listed: 176364, 178346, 181337, 185213, 186561, 189709, 190559, 193643, or 195763A1.
The Rio System Irrigation Clip is used with the RESTORIS Partial Knee Application (PKA) for surgical procedures involving knee replacements, specifically for providing software-defined spatial boundaries during orthopedic surgeries.
Affected lots include 176364, 178346, 181337, 185213, 186561, 189709, 190559, 193643, and 195763A1.
The recall record does not specify a remedy for the out of tolerance hazard.
We’ve drafted a message you can send Mako Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-2794-2018 — Mako Surgical Mako Surgical Hello, I own a Mako Surgical that is covered by recall Z-2794-2018 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.
