NOBELREPLACE Tapered Groovy RP 4.3x8mm, Article No. 32215. Nobel Biocare's Dental Implants are root-form endosseous impl

FDA device recall Z-1419-2015 · posted 2015-04-13 · Terminated

Recall details

Recalling firm

Nobel Biocare Usa Llc

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.

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

DZE

Quantity affected

138 units

Distribution

Worldwide Distribution - US (nationwide) and Internationally to Austria, Australia, Belgium, Bulgaria, Canada, Switzerland, Czech Republic, Germany, Denmark, Estonia, Spain, Finland, France, United Ki

Date initiated

2015-03-09

Date posted

2015-04-13

Date terminated

2015-12-30

Location

Yorba Linda, CA

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