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Restoris Multicompartmental Knee (MCK) System is an implant… recallZ-1132-2014 · Mako Surgical Corporation · initiated Jan 9, 2014

Class II Terminated All recalls posted in March 2014

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Mako Surgical Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

The product may be mislabeled and could result in the incorrect implant being used.

FDA root cause category: Error in labeling

What the company is doing

MAKO Surgical Corporation sent an Important Medical Device Recall Notice letter dated January 9, 2014 to all affected customers. The letter identified the product, the problem, and the actions to be taken by the customer. The letter informed the customers that their MAKOplasty Sales Specialist will coordinate with them the return of the product that will be replaced at no charge. Customers were asked to sign and return the Acknowledgement form to MAKO Surgical using one of the following methods: Email, Fax or Mail. For questions, customers were instructed to call (954) 628-1721. For questions regarding this recall call 954-628-0607.

Recall details

Recall number
Z-1132-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Jan 9, 2014
Posted by the FDA
Mar 4, 2014
Recalling firm
Mako Surgical Corporation
Quantity
41 units
Product code
NPJ
FDA submissions
K090763
Distribution
Nationwide distribution including AZ, FL, HI, OH, MI, NC NH, WA, TX, WI, OK, CA, RI, LA, ID, IL, IN, and TN.

Product description

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 Restoris MCK Uni is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees. In Restoris MCK combination where multi-compartmental areas are being treated, the Restoris MCK components were designed with 3 mm of gap between the components to ensure that the components do not interfere. Is indicated for single or multi-compartmental knee replacement used in conjunction with RIO, in individuals with osteoarthritis or post-traumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces.

Code information (models, lots, serial numbers)

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

Other devices under the same FDA submission

68 devices cleared under K090763 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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