Z-3131-2017 Class II Terminated
FDA device recall Z-3131-2017 was initiated by Mako Surgical Corporation on August 7, 2017 and is designated Class II. Reason for recall: Software discrepancy of not showing all the EE constants, when the screen is filled. The recall status is terminated (terminated August 6, 2019). Affected quantity: 291 (US) and 66 (OUS).
Recall Details
- Product Type
- Devices
- Report Date
- September 20, 2017
- Initiation Date
- August 7, 2017
- Termination Date
- August 6, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 291 (US) and 66 (OUS)
Product Description
Reason for Recall
Distribution Pattern
Worldwide - US Nationwide Distribution in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI and WY and the countries of Australia, Taiwan, China, Taiwan, Hong Kong, Greece, United Kingdom, England, Netherlands, Luxembourg, Ireland, Italy, Germany, India, Japan, Korea, Singapore, Thailand, Vietnam, South Africa, and Turkey