Abutment Retrieval Instrument Zirconia CC RP/WP, Article No. 37882 and Abutment Retrieval Kit, Article No. 37508 (Articl

FDA device recall Z-2074-2015 · posted 2015-07-15 · Terminated

Recall details

Recalling firm

Nobel Biocare Usa Llc

Reason for recall

One dimension of the affected instrument is incorrect. Therefore this instrument cannot be used to remove the metal adapter as intended.

Action taken

A customer notification letter dated 6/22/15 will be sent to all customers who purchased the Abutment Retrieval Instrument Zirconia CC RP/WP because an internal investigation showed that one dimension of the affected instrument is incorrect. Therefore this instrument cannot be used to remove the metal adapter as intended. The letter provides the problems identified and the actions to be taken. Customers are instructed to complete the acknowledgement form and return it to their local Nobel Biocare Subsidiary with the affected instrument. Customers with the affected instrument that is a part of a kit, Nobel Biocare Representative will contact them directly. Customers with any remaining questions, are instructed to contact their Nobel Biocare Representative.

Root cause

Under Investigation by firm

Status

Terminated

Product code

NDP

Quantity affected

149 units total

Distribution

Worldwide Distribution-US (nationwide) and the countries of Australia, Austria, Belgium, Canada, Finland, France, Germany, Greece, Hong Kong, Hungary, Italy, Luxembourg, Netherlands, New Zealand, Norw

Date initiated

2015-06-22

Date posted

2015-07-15

Date terminated

2015-09-18

Location

Yorba Linda, CA