NobelReplace CC PMC RP 4.3x8mm, Article No. 37290.
Reported: April 22, 2015 Initiated: March 9, 2015 #Z-1437-2015
Product Description
NobelReplace CC PMC RP 4.3x8mm, Article No. 37290.
Reason for Recall
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.
Details
- Recalling Firm
- Nobel Biocare Usa Llc
- Units Affected
- 2 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.
- Location
- Yorba Linda, CA
Frequently Asked Questions
What product was recalled? ▼
NobelReplace CC PMC RP 4.3x8mm, Article No. 37290.. Recalled by Nobel Biocare Usa Llc. Units affected: 2 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 22, 2015. Severity: Moderate. Recall number: Z-1437-2015.
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