NobRpl Tapered Groovy 6.0mm 6x11.5mm recall
NobRpl Tapered Groovy 6.0mm 6x11.5mm, Article No. 36103. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically…
Why was NobRpl Tapered Groovy 6.0mm 6x11.5mm recalled?
A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
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?
Batch No. 113010001.
- Product
- NobRpl Tapered Groovy 6.0mm 6x11.5mm, Article No. 36103. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically…
- Recalling firm
- Nobel Biocare Usa Llc
- Quantity
- 72 units
- Distribution
- Worldwide Distribution - US (nationwide) and Internationally to Austria, Australia, Belgium, Bulgaria, Canada, Switzerland, Czech Republic, Germany, Denmark, Estonia, Spain, Finland, France, United Kingdom, Greece, Croatia, Hungary, Ireland, Italy, Lithuania, Luxembourg, Mexico, Netherlands, Norway, Poland, Portugal, Romania, Russian Fed., Saudi Arabia, Sweden, Turkey, and United Arab Emirates.
- Recall date
- April 22, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)