Z-1644-2018 Class II Terminated
FDA device recall Z-1644-2018 was initiated by Mako Surgical Corporation on December 1, 2017 and is designated Class II. Reason for recall: Incorrect product and/or label. Sizing is labeled incorrectly. The recall status is terminated (terminated December 14, 2020). Affected quantity: 126.
Recall Details
- Product Type
- Devices
- Report Date
- May 16, 2018
- Initiation Date
- December 1, 2017
- Termination Date
- December 14, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 126
Product Description
RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements.
Reason for Recall
Incorrect product and/or label. Sizing is labeled incorrectly.
Distribution Pattern
AL, AR, AZ, CA, CO, FL, GA, ID, IL, IN, KS, LA, MA, MD, MI, MN, NC, NE, NH, NJ, NY, OK, OR, PA, RI, SC, TX, UT, VA, WA, WY, and Hawaii Australia, Italy, Netherlands, Singapore, South Korea, United Kingdom, and Vietnam
Code Information
Size 2 Item # 180612 Lot # 26080317-01 and Size 7 Item # 180617 Lot # 26150217-01.