Replace Select Tapered TiU RP 4.3x11.5mm, Article No. 36107.
- Company
- Nobel Biocare Usa Llc
- Recall Initiated
- March 9, 2015
- Posted
- April 13, 2015
- Terminated
- December 30, 2015
- Recall Number
- Z-1424-2015
- Quantity
- 32 units
- Firm Location
- Yorba Linda, CA
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.
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.
Lot / Code Info
Batch No. 13011452, 13011453.
Root Cause
Nonconforming Material/Component
Action Taken
Nobel Biocare sent an Important - Field Correction letter dated March 6, 2015, to all affected customers and another recall letter dated dated March 10, 2015, to all affected customers to inform them that Nobel Biocare Quality Management Systems observed an issue with a material used in the packaging of their implants. The firm's internal analysis has confirmed that this material is not according to their standards. The letters provide the problems identified and the actions to be taken. Customers were instructed to return the affected product(s) not yet used to Nobel Biocare to receive a replacement product. Customers were also instructed to complete the attached Acknowledgement form and fax it to 714-282-5073 or email it to aeinfo@nobelbiocare.com. Customers with questions were instructed to contact their customer service department. For questions regarding this recall call 714-282-4800.