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Recall Observatory FDA recall evidence

Device product

RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements.

Z-1644-2018

December 01, 2017

Class II

Product summary

Firm
Mako Surgical Corporation
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

    reason.no_named_rule · v1.0.0

    Incorrect product and/or label. Sizing is labeled incorrectly.