Skip to content
Lower risk Medical device recall · FDA · Published April 25, 2019

Mako 2.7 Degree Angled Sagittal Saw Recall: Ungreased Bearings Risk

Mako Surgical recalls 2.7 Degree Angled Sag: Ungreased bearings may cause malfunction during total knee surgery. Affected units have specific catalog and lot numbers.

🇺🇸 FDA recall #Z-1823-2019Medical deviceMako ›
Take action

Contact the company

Recalling firmMako Surgical Corporation2555 Davie Rd Ste 110 · Davie, FL 33317-7424
✎ GovInfoNow plain-language explainer

What happened, in plain English

Mako Surgical is recalling a 2.7-degree angled sagittal saw attachment for total knee surgery. The recall is due to ungreased bearings, which could lead to improper function during surgical procedures. Read more at govinfonow.com/recall/68021-mako-2-7-degree-angled-sagittal-saw-recall-ungreased-bearings.

Source Summary by GovInfoNow · govinfonow.com/recall/68021-mako-2-7-degree-angled-sagittal-saw-recall-ungreased-bearings · Updated August 17, 2026 · FDA enforcement record: FDA #Z-1823-2019

Cite this page

“Mako 2.7 Degree Angled Sagittal Saw Recall: Ungreased Bearings Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/68021-mako-2-7-degree-angled-sagittal-saw-recall-ungreased-bearings. Based on FDA recall #Z-1823-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1823-2019%22&limit=1).

Why it’s dangerous

The saw attachment's bearings were ungreased, which could cause the attachment to become stiff or malfunction during surgery. This might lead to improper cutting or damage to the surgical site.

Who’s affected

Surgical teams using the Mako Total Knee system with this specific attachment are affected. Surgeons and surgical staff are most at risk during procedures.

How to tell if you have this one

Check for the catalog number 212480 and lot number 35040918 on the attachment. The product is only used with Mako Total Knee systems.

  • Brand
    Mako
  • Product
    2.7 Degree Angled Sagittal Saw attachment (Mako Total Knee Application Only)
  • Category
    Medical device
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    AR, CA, FL, KS, MA, MO, NC, NJ, NY, OH, OR, TN, and TX. Australia, China and Netherlands
Recall numberProduct, codes & lotsQuantity
Z-1823-20192.7 Degree Angled Sagittal Saw attachment (Mako Total Knee Application Only); Catalog Number: 212480 Lot Number: 35040918 UDI: (01)00848486032128(10)3504091839
Z-1824-20192.7 Degree Straight Sagittal Saw attachment (Mako Total Knee Application and Partial Knee Application 3.0); Catalog Number: 212186 Lot Number: 35051018 and 35050918 UDI: (01)00848486032111(10)35051018 and (01)00848486032111(10)350509187
Based on the official FDA remedy

What to do — step by step

  1. Check Attachment Details

    Look for catalog number 212480 and lot number 35040918 on the attachment.

Where it went and when

Where it was distributed

Distributed in 13 states, and outside the U.S.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: yesNYRhode Island: not listedRIMassachusetts: yesMAOregon: yesORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: yesOHPennsylvania: not listedPANew Jersey: yesNJConnecticut: not listedCTCalifornia: yesCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: yesMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: yesTXFlorida: yesFL

FDA distribution: “AR, CA, FL, KS, MA, MO, NC, NJ, NY, OH, OR, TN, and TX. Australia, China and Netherlands” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Arkansas, California, Florida, Kansas, Massachusetts, Missouri, New Jersey, New York, North Carolina, Ohio, Oregon, Tennessee, Texas.

Recall timeline

FDA terminated this recall 2 years after the firm started it.

1. Firm started the recall: Apr 25, 201912. FDA classified it Class II: Jun 15, 201923. Published in FDA’s Enforcement Report: Jun 26, 201934. FDA terminated the recall: Apr 22, 2021420192021
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

Is this product safe to use?

The recall states the bearings were ungreased, which could cause malfunction during surgery. The product is not safe to use without addressing the issue.

Similar recalls

Latest medical device recalls

Keep exploring

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-1823-2019 (April 25, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1823-2019 to see it in context.
  • Plain-language summary written by qwen3:4b on August 17, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA