FDAFDA · Food and drugs·Recall number Z-1644-2018
RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements.
Published May 16, 2018 · Recall initiated: December 1, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Incorrect product and/or label. Sizing is labeled incorrectly.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Mako Surgical Corporation
- Distributor
- 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
- Lot
- Size 2 Item # 180612 Lot # 26080317-01 and Size 7 Item # 180617 Lot # 26150217-01.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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