Medtronic Recalls Sagittal Saw Devices Due to Potential Fluid Leakage
Medtronic is recalling 368 Sagittal Saw devices because testing identified a potential for fluid leakage into the motor during use.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (surgical saw) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Medtronic Sofamor Danek USA, Inc. is recalling 368 units of the Sagittal Saw, including catalog numbers ES 300, ES300-R, ES310, and ES310-R. These devices are used to dissect bone in surgical applications.
The recall was initiated after Medtronic Powered Surgical Solutions testing identified a potential for leakage of fluid into the motor during use. The agency has classified this as a Class II recall.
The affected devices were distributed worldwide, including in the United States states of AL, AR, AZ, CA, CT, FL, GA, IA, ID, IL, IN, MA, MD, NC, NH, NY, SC, TN, TX, and UT. All serial numbers are included in this recall.
The recalled product
- Product
- Saw Sagittal Catalog Number: ES 300; Saw Sagittal Refurbished Catalog Number: ES300-R; Saw Saggital, Finger Catalog Number: ES310; Saw Saggital, Finger Refurbished Catalog Number: ES310-R; Used to dissect bone in surgical applications.
- Hazard
- Affected units
- 368
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Serial Numbers.
Distribution
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