Mako Surgical Corporation: Medical Device Recall in 2018 - (Recall #: Z-1644-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: December 1, 2017

Date Posted: May 16, 2018

Recall Number: Z-1644-2018

Event ID: 79585

Reason for Recall:

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

Status: Terminated

Product Quantity: 126

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

Voluntary or Mandated:

Voluntary: Firm initiated