Device product
RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements.
Z-1644-2018
Product summary
- Event
- Event 79585
- Status
- Terminated
- Classification
- Class II
- Quantity
- 126
- Official record key
device-enforcement:Z-1644-2018
Official wording
Reason: Incorrect product and/or label. Sizing is labeled incorrectly.
Code information: Size 2 Item # 180612 Lot # 26080317-01 and Size 7 Item # 180617 Lot # 26150217-01.
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
Derived failure modes
-
Unknown
Incorrect product and/or label. Sizing is labeled incorrectly.