Mako Surgical Recalls 2.7 Degree Angled Sagittal Saw Attachments
Mako Surgical Corporation is recalling 39 units of the 2.7 Degree Angled Sagittal Saw attachment because the bearings were ungreased.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any injuries, illnesses, or hospitalizations. The defect (ungreased bearings) is a functional issue without reported harm, fitting the criteria for a moderate severity score.
Plain-English summary
Mako Surgical Corporation is recalling 39 units of the 2.7 Degree Angled Sagittal Saw attachment, which is used exclusively for the Mako Total Knee Application. The recall was initiated because the bearings of the saw attachments were found to be ungreased.
The affected products are identified by Catalog Number 212480 and Lot Number 35040918. The UDI for these units is (01)00848486032128(10)35040918. The devices were distributed to facilities in the United States (AR, CA, FL, KS, MA, MO, NC, NJ, NY, OH, OR, TN, and TX) and internationally in Australia, China, and the Netherlands.
Healthcare providers and facilities should check their inventory for this specific catalog and lot number. If the product is found, it should be removed from use and returned to Mako Surgical Corporation in accordance with their instructions.
The recalled product
- Product
- 2.7 Degree Angled Sagittal Saw attachment (Mako Total Knee Application Only)
- Manufacturer
- Mako Surgical Corporation
- Hazard
- Affected units
- 39
Distribution
Part of a larger recall action
This product is one of 2 recalled by Mako Surgical Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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