Z-2741-2017 Class II Terminated
FDA device recall Z-2741-2017 was initiated by Mako Surgical Corporation on June 7, 2017 and is designated Class II. Reason for recall: An intermittent electrical problem that could lead to a loss of system power due to a loose screw connection. The recall status is terminated (terminated June 16, 2020). Affected quantity: 20.
Recall Details
- Product Type
- Devices
- Report Date
- July 26, 2017
- Initiation Date
- June 7, 2017
- Termination Date
- June 16, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20
Product Description
MAKO RIO Standard System, internal cPCI Card CageP/N: 201337. Intended to assist the surgeon in providing software defined spatial boundaries during orthopedic procedures.
Reason for Recall
An intermittent electrical problem that could lead to a loss of system power due to a loose screw connection.
Distribution Pattern
Distributed to the states of AZ, CA, CO, CT, FL, GA, ID, LA, MA, MO, MS, NC, OH, PA, TN, TX, & WA.
Code Information
Lot No. 05212015