Mako Surgical RESTORIS MCK Tibial Baseplate Recall: Incorrect Sizing Labels
Mako Surgical recalls RESTORIS MCK Tibial Baseplates with incorrect sizing labels that could lead to improper fit during knee replacement surgery. Affected items include specific sizes and lot numbers.
Lower-risk recall
Incorrect product and/or label. Sizing is labeled incorrectly.
Contact the company
What happened, in plain English
Mako Surgical is recalling RESTORIS MCK Tibial Baseplates used in knee replacements due to incorrect sizing labels. This could cause improper fit during surgery, potentially leading to complications. Read more at govinfonow.com/recall/72411-mako-surgical-restoris-mck-tibial-baseplate-recall-incorrect-sizing-labels.
Source Summary by GovInfoNow · govinfonow.com/recall/72411-mako-surgical-restoris-mck-tibial-baseplate-recall-incorrect-sizing-labels · Updated August 31, 2026 · FDA enforcement record: FDA #Z-1644-2018
Cite this page
“Mako Surgical RESTORIS MCK Tibial Baseplate Recall: Incorrect Sizing Labels.” GovInfoNow, updated August 31, 2026. https://govinfonow.com/recall/72411-mako-surgical-restoris-mck-tibial-baseplate-recall-incorrect-sizing-labels. Based on FDA recall #Z-1644-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1644-2018%22&limit=1).
Why it’s dangerous
Incorrect sizing labels could lead to using the wrong size baseplate during knee replacement surgery. This might cause improper fit, potentially leading to complications like instability or misalignment.
Who’s affected
Surgical teams using RESTORIS MCK Tibial Baseplates for knee replacements are affected. Patients undergoing these procedures may be at risk if the wrong size is used.
How to tell if you have this one
Check for RESTORIS MCK Tibial Baseplate-RM/LL with specific sizes: Size 2 (Item # 180612, Lot # 26080317-01) or Size 7 (Item # 180617, Lot # 26150217-01).
- Brand
Mako Surgical- Category
Medical device
What to do — step by step
Check Product Labels
Verify the size and lot number on the baseplate to confirm if it matches the affected models.
Where it went and when
Where it was distributed
Distributed in 32 states, and outside the U.S.
FDA distribution: “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” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, Arizona, Arkansas, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Nebraska, New Hampshire, New Jersey, New York, North Carolina, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Texas, Utah, Virginia, Washington, Wyoming.
Recall timeline
FDA terminated this recall 3 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to stop using the baseplate immediately?
No immediate stop is required; check the labels to confirm if your baseplate is affected.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1644-2018 (December 1, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1644-2018 to see it in context.
- Plain-language summary written by qwen3:4b on August 31, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.