The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1132-2014·Announced 2014-03-12

Mako Surgical Recalls Restoris Multicompartmental Knee System Due to Mislabeling

Mako Surgical Corporation is recalling 41 units of the Restoris Multicompartmental Knee System because the product may be mislabeled, which could result in the incorrect implant being used.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error that could lead to the use of an incorrect implant. Per the rubric, minor labeling errors and low-risk contamination are classified as Moderate (Score 2), as there are no reported injuries or fatalities and the hazard is procedural rather than a direct toxicological or structural failure.

Plain-English summary

Mako Surgical Corporation is recalling 41 units of the Restoris Multicompartmental Knee (MCK) System. This implant system is designed for use with MAKO's Robotic Arm Interactive Orthopedic System (RIO) and is indicated for single or multi-compartmental knee replacement in individuals with osteoarthritis or post-traumatic arthritis. The specific units involved are identified by Part Number #180704-1 and Lot #12151013-1.

The recall was initiated because the product may be mislabeled. This labeling error could result in the incorrect implant being used during a surgical procedure. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

The affected units were distributed nationwide, including in Arizona, Florida, Hawaii, Ohio, Michigan, North Carolina, New Hampshire, Washington, Texas, Wisconsin, Oklahoma, California, Rhode Island, Louisiana, Idaho, Illinois, Indiana, and Tennessee. Healthcare providers and facilities that have received these specific units should stop using them and contact Mako Surgical Corporation for instructions on how to return the product.

The recalled product

Product
Restoris Multicompartmental Knee (MCK) System is an implant system designed to be used with MAKO's Robotic Arm Interactive Orthopedic System (RIO). It is composed of a unicompartmental implant system (Restoris MCK Uni) and a patellofemoral implant system (Restoris MCK PF). The…
Manufacturer
Mako Surgical Corporation
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
41

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Part Number #180704-1
  • Lot #12151013-1.

Distribution

Distributed nationwide across the United States.

The notice also names 18 states specifically:

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