Restoris Multicompartmental Knee (MCK) System is an implant system designed to be used with MAKO's Robotic Arm Interacti

FDA device recall Z-1132-2014 · posted 2014-03-04 · Terminated

Recall details

Recalling firm

Mako Surgical Corporation

Reason for recall

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

Action taken

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

Status

Terminated

Product code

NPJ

Quantity affected

41 units

Distribution

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

Date initiated

2014-01-09

Date posted

2014-03-04

Date terminated

2014-08-14

Location

Plantation, FL

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