Mako Surgical recalls Makoplasty RIO Standard System (Ethernet to Fiber Optic Converter) due to communication-connection errors in partial knee surgery. Affected units include all lots for the Partial Knee Application.
Communication-connection error.
Mako Surgical is recalling its Makoplasty RIO Standard System (Ethernet to Fiber Opt: Converter) for potential communication errors during partial knee surgery. This recall affects all units sold for the Partial Knee Application, which is used in specific surgical procedures.
The system uses Ethernet to fiber optic converters for surgical guidance. A communication-connection error could disrupt the system's ability to accurately guide the surgery, potentially leading to incorrect bone alignment or procedure errors.
Surgical teams using the Makoplasty RIO Standard System for partial knee replacements are affected. Patients undergoing these procedures with the system are at risk if the communication error occurs.
Check for the Makoplasty RIO Standard System with Catalog # 200933. This product is used for the Partial Knee Application in surgical knee procedures. All lots are affected.
Identify the product by checking for Catalog # 200933 and the Partial Knee Application label.
The recall states there is a communication-connection error hazard, but no specific remedy is provided. The product may not be safe for use as described.
Look for the Makoplasty RIO Standard System with Catalog # 200933 used for the Partial Knee Application. All lots are affected.
The recall does not specify a remedy, so no action is required beyond checking if you have the product.
We’ve drafted a message you can send Mako Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-3182-2018 — Mako Surgical Mako Surgical Hello, I own a Mako Surgical that is covered by recall Z-3182-2018 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.
