Mako Surgical Recalls 2.7 Degree Straight Sagittal Saw Attachments
Mako Surgical Corporation is recalling 2.7 Degree Straight Sagittal Saw attachments because the bearings were ungreased. The devices were distributed to facilities in 13 US states and three international countries.
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 quality control issue that poses a theoretical risk of device malfunction, fitting the criteria for a moderate severity score.
Plain-English summary
Mako Surgical Corporation is recalling seven units of the 2.7 Degree Straight Sagittal Saw attachment, used for Mako Total Knee Application and Partial Knee Application 3.0. The recall was initiated because the bearings of the saw attachments were ungreased.
The affected devices are identified by Catalog Number 212186 and Lot Numbers 35051018 and 35050918. The products 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 facilities should stop using the affected devices and contact Mako Surgical Corporation for instructions on return or replacement.
The recalled product
- Product
- 2.7 Degree Straight Sagittal Saw attachment (Mako Total Knee Application and Partial Knee Application 3.0)
- Manufacturer
- Mako Surgical Corporation
- Hazard
- Affected units
- 7
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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