Mako Surgical MICS Handpiece Software Issue: Checkpoint Verification Failure Risk
Mako Surgical recalls specific MICS Handpiece models with software versions THA 3.0 and later that may cause bone preparation errors during knee surgery. Affected units have serial numbers listed in the recall notice.
Lower-risk recall
Stryker has discovered a characterization issue associated with the Mako Integrated Cutting System (MICS) Handpiece. The MICS Handpiece is attached to the distal end of the robotic arm and is used to register the RIO and to execute bone preparation during a Mako Total Knee or Mako Partial Knee procedure (PKA Software Application 3.0 or later). This issue may result in unsuccessful checkpoint verification when the Mako System attempts to verify the location of the saw blade prior to bone preparation. This issue may also cause a discrepancy during bone preparation in a Mako Total Knee or a Mako Partial Knee procedure in which the surgeon uses a straight or angled saw attachment with the MICS Handpiece. The surgeon may make cuts during bone preparation that differ from the surgeon s preoperative plan.
Contact the company
What happened, in plain English
Mako Surgical is recalling certain MICS Handpieces with software versions THA 3.0 and later that may cause bone preparation errors during knee surgery. This could lead to cuts differing from the surgeon's preoperative plan. Read more at govinfonow.com/recall/64055-mako-surgical-mics-handpiece-software-issue-checkpoint-verification-failure-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/64055-mako-surgical-mics-handpiece-software-issue-checkpoint-verification-failure-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0472-2021
Cite this page
“Mako Surgical MICS Handpiece Software Issue: Checkpoint Verification Failure Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64055-mako-surgical-mics-handpiece-software-issue-checkpoint-verification-failure-risk. Based on FDA recall #Z-0472-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0472-2021%22&limit=1).
Why it’s dangerous
The handpiece has a characterization issue that may cause unsuccessful checkpoint verification before bone preparation. This could result in the surgeon making cuts that differ from their preoperative plan during knee surgery.
Who’s affected
Surgeons using the Mako Total Knee or Mako Partial Knee systems with the recalled handpieces. The risk is primarily for medical professionals performing these procedures.
How to tell if you have this one
Check for serial numbers listed in the recall notice (4200052, 4200095, and other numbers provided). The handpiece has software version THA 3.0 or later for Total Knee procedures and PKA 3.0 or later for Partial Knee procedures.
- Brand
Mako Surgical- Product
Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: THA 3.0 and later, PKA 3.0- Category
Medical device
What to do — step by step
Check Software Version
Verify the software version on your MICS Handpiece. If it's THA 3.0 or later for Total Knee procedures or PKA 3.0 or later for Partial Knee procedures, it may be affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution - US Nationwide distribution and the countries of Australia, Japan, Korea, Netherlands, and Chile, and France, Germany Luxembourg, and UK” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 33 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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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-0472-2021 (October 23, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0472-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 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.