Medtronic Mazor X Surgical System Positioner Recalled for Detachment Risk
Medtronic is recalling 177 Mazor X Surgical System Positioner Type II units because they may unexpectedly detach from the operating table, posing a risk of blunt injury to patients.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a structural defect in a medical device that could cause significant physical injury (fractures, hemorrhage) to patients, meeting the criteria for a Severe (Score 4) classification.
Plain-English summary
Medtronic Navigation, Inc. is recalling 177 units of the Mazor X Surgical System Positioner Type II (REF: ASM0214-02). The recall covers all lots of the product. The devices were distributed to facilities in 30 U.S. states and 12 countries, including Australia, China, India, and the United Kingdom.
The recall is being issued because there is a potential for the surgical system to detach from the operational room table unexpectedly. If this occurs, the surgical system could fall onto the patient, resulting in blunt injury such as hemorrhage, hematoma, bleeding, or fractures.
The source text does not specify specific actions for consumers or healthcare providers, such as whether to stop using the device or contact the manufacturer. Healthcare facilities should verify if they possess the affected product and follow instructions from Medtronic or the FDA.
The recalled product
- Product
- Mazor X Surgical System Positioner Type II, REF: ASM0214-02
- Manufacturer
- Medtronic Navigation, Inc.
- Affected units
- 177
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 Lots
Distribution
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