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Terminated

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.

FDA Recall Z-1132-2014 · Posted 2014-03-04

Recalling FirmMako Surgical Corporation
Recall StatusTerminated
Product CodeNPJ
Date Initiated2014-01-09
Date Terminated2014-08-14
Product Quantity41 units

Reason for Recall

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

Firm Action

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.

Root Cause

Error in labeling

Distribution Pattern

Nationwide distribution including AZ, FL, HI, OH, MI, NC NH, WA, TX, WI, OK, CA, RI, LA, ID, IL, IN, and TN.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K090763RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEMMako Surgical Corporation · 2009-06-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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