Mazor X Surgical System Positioner Type II recall
Mazor X Surgical System Positioner Type II, REF: ASM0214-02
Why was Mazor X Surgical System Positioner Type II recalled?
There is a potential for the surgical system to detach from the operational room table unexpectedly. This could result in the surgical system falling onto the patient resulting in blunt injury [hemorrhage, hematoma, bleeding, or fracture(s)]
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All Lots
- Product
- Mazor X Surgical System Positioner Type II, REF: ASM0214-02
- Recalling firm
- Medtronic Navigation, Inc.
- Quantity
- 177 Systems
- Distribution
- US: ALAR,AZ,CA,CO,CT,FL,GA,IA,ID,IL,IN,KY,MA,MI,MN,MO,NC,ND,NL,NY,OH,PA,SC,TN,TX,UT,VA,WA,WI,WV, OUS: Australia, China, India, Israel, Romania, Singapore, Thailand, United Kingdom, Switzerland, Spain, Germany, Belgium,
- Recall date
- June 17, 2020
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)