Z-1132-2014 Class II Terminated
FDA device recall Z-1132-2014 was initiated by Mako Surgical Corporation on Jan 9, 2014 and is designated Class II. Reason for recall: The product may be mislabeled and could result in the incorrect implant being used. The recall status is terminated (terminated Aug 14, 2014). Affected quantity: 41 units.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 12, 2014
- Initiation Date
- Jan 9, 2014
- Termination Date
- Aug 14, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 41 units
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.
Reason for Recall
The product may be mislabeled and could result in the incorrect implant being used.
Distribution Pattern
Nationwide distribution including AZ, FL, HI, OH, MI, NC NH, WA, TX, WI, OK, CA, RI, LA, ID, IL, IN, and TN.
Code Information
Part Number #180704-1, Lot #12151013-1.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1132-2014
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026