PlainRecalls
FDA Devices Moderate Class II Terminated

Abutment Retrieval Instrument Zirconia CC RP/WP, Article No. 37882 and Abutment Retrieval Kit, Article No. 37508 (Article No. 37882 was assembled in this kit). Used to remove a zirconia abutment if the abutment is stuck in the implant connection due to a tight seat. Endosseous dental implant instrument.

Reported: July 22, 2015 Initiated: June 22, 2015 #Z-2074-2015

Product Description

Abutment Retrieval Instrument Zirconia CC RP/WP, Article No. 37882 and Abutment Retrieval Kit, Article No. 37508 (Article No. 37882 was assembled in this kit). Used to remove a zirconia abutment if the abutment is stuck in the implant connection due to a tight seat. Endosseous dental implant instrument.

Reason for Recall

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

Details

Recalling Firm
Nobel Biocare Usa Llc
Units 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, Norway, Portugal, South Africa, Spain, Switzerland, and United Kingdom.
Location
Yorba Linda, CA

Frequently Asked Questions

What product was recalled?
Abutment Retrieval Instrument Zirconia CC RP/WP, Article No. 37882 and Abutment Retrieval Kit, Article No. 37508 (Article No. 37882 was assembled in this kit). Used to remove a zirconia abutment if the abutment is stuck in the implant connection due to a tight seat. Endosseous dental implant instrument.. Recalled by Nobel Biocare Usa Llc. Units affected: 149 units total.
Why was this product recalled?
One dimension of the affected instrument is incorrect. Therefore this instrument cannot be used to remove the metal adapter as intended.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 22, 2015. Severity: Moderate. Recall number: Z-2074-2015.