Mako 210490Recalls & reported problems
Mako Surgical Corp. · MICS Sagittal Saw Attachment , Angled · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613327523874), received between Oct 6, 2025 and Feb 19, 2026 — classified as 1 injury, 8 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (9 reports).
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Feb 2, 2026Open, Classified
A potential issue was identified with the torque strength on the external screws of the MICS3 Angled Sagittal Saw Attachment. These screws, which secure the cover to the Angled Saw Housing, may loosen during use and detach from the attachment.
Z-1572-2026 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Detachment of Device or Device Component9
Patient problems
- No Clinical Signs, Symptoms or Conditions8
- Insufficient Information1
- Joint Impingement1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 19, 2026Detachment of Device or Device Component
DURING FIRST BONE CUT SMALL SCREW ON FRONT OF NEW STYLE ANGLED ATTACHMENT FELL OUT ONTO STERILE FIELD. DID NOT FALL INTO WOUND. NO DELAY IN CASE. ATTACHMENT STILL WORKED FOR CASE. PATIENT UNDER ANESTHESIA. TOURNIQUET WAS IN USE. CASE TYPE / APPLICATION: TKA 2.1.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24393944 ↗MalfunctionFeb 3, 2026Detachment of Device or Device Component
THE FOLLOWING INFORMATION WAS PROVIDED: SCREW FELL OUT OF THE NEW ANGLED SAW ATTACHMENT AND INTO THE PATIENTS WOUND. SURGEON RETRIEVED THE SCREW AND CONFIRMED IT WAS THE ONLY ONE MISSING FROM THE SAW AND THAT IT WAS FULLY INTACT. CASE TYPE / APPLICATION: TKA 2.1.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24246330 ↗MalfunctionJan 19, 2026Detachment of Device or Device Component
NEW ANGLED SAW ATTACHMENT USED FOR A MAKO TKA. AFTER USING FOR INTENDED USE, WE NOTICED THAT ONE OF THE SCREWS WAS MISSING. WAS ABLE TO LOCATE IT AMONGST THE STERILE DRAPES. TKA 2.0.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24108997 ↗MalfunctionJan 19, 2026Detachment of Device or Device Component
TWO SCREWS CAME LOOSE AND FELL OUT INTO THE PATIENT DURING BONE CUTS. CASE TYPE / APPLICATION: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24108957 ↗MalfunctionJan 12, 2026Detachment of Device or Device Component
THE FOLLOWING INFORMATION WAS PROVIDED: SCREW FELL OUT OF ATTACHMENTCASE TYPE / APPLICATION: TKA 2.1
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24037161 ↗MalfunctionDec 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23836560 ↗MalfunctionDec 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ANGLE SAW BLADE ATTACHMENT LOST SCREW IN MIDDLE OF CASE. CASE TYPE: TKA 2.0.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23766042 ↗MalfunctionNov 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23574880 ↗InjuryOct 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT UPON 2 WEEK FOLLOW-UP FOR A LEFT MAKO TKA 2.1, AN OBJECT WAS SEEN IN THE PATIENT'S KNEE ON X-RAY. THE MAKO 4 TRAYS WERE SEARCHED, AND A MICS 3 ANGLED SAW ATTACHMENT WAS FOUND TO BE MISSING A SCREW. SURGEON PLAN IS TO REMOVE THE SCREW ON (B)(6) 2025. UPDATE 15/SEPTEMBER/2025: SCREW WAS REMOVED (SURGEON SCOPED IT OUT OF THE JOINT) AND WILL BE RETURNED WITH THE SAW ATTACHMENT.
Patient problems: Insufficient Information; Joint Impingement
MAUDE report 23220729 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.