Disposable recall
Disposable Reflective Marker Spheres The Disposable Reflective Marker Spheres used in conjunction with a stereotaxic instrument consisting of a rigid…
Why was Disposable recalled?
Disposable Reflective Marker Spheres (DRMS) for Brainlab Image Guided Surgery (IGS) Systems: DRMS spheres may separate at the mid-point where the two halves of the sphere are sealed together.
What should I do if I have this product?
Review the official FDA enforcement record for current 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?
Model numbers: 41773G Disposable Reflective Marker Sphere (90 Pcs.) 41774G Disposable Reflective Marker Sphere (270 Pcs.) 41772G Disposable Reflective Marker Sphere (3 Pcs) Catalogue numbers: 41773G Disposable Reflective Marker Sphere (90 Pcs.) 41774G Disposable Reflective Marker Sphere (270 Pcs.) (Note: 41772G is not available as single item for sale, but contained in the above 41773G or 41774G) Lot Numbers: 1014213001, C103461502, C107761402, C100111501, C1034813001, C108341301, C101021502, C103881402, C108721402, C101161401, C104761402, C109051301, C101611502, C105541402, C109251402, C102311401, C106521402, C1098312001, C102481502, C106721301 and C110411401.
- Product
- Disposable Reflective Marker Spheres The Disposable Reflective Marker Spheres used in conjunction with a stereotaxic instrument consisting of a rigid…
- Recalling firm
- Brainlab AG
- Quantity
- For 28 US consignees, 9,900 Disposable reflective marker spheres ***For 451 non-US consignees, 359,280 Disposable reflective marker spheres
- Distribution
- Worldwide Distribution: US (nationwide) including states of: TX, CA, TN, NY, LA, IL, MA, PA, OH, AZ, ID, CT, MI, and KY; and countries of: Algeria, Argentina, Australia, Bahrain, Belarus, Bolivia, Brazil, Chile, China, Colombia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, Germany, Hong Kong, Hungary, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Kazakhstan, Korea, Kuwait, Libya, Lithuania, Malaysia, Malta, Mexico, Moldova, Morocco, Myanmar, Netherlands, Philippines, Poland, Portugal, Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, , Venezuela, and Vietnam.
- Recall date
- September 30, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)