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Recall Observatory FDA recall evidence

Device product

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.

Z-2074-2015

June 22, 2015

Class II

Product summary

Firm
Nobel Biocare Usa Llc
Event
Event 71552
Status
Terminated
Classification
Class II
Quantity
149 units total
Official record key
device-enforcement:Z-2074-2015

Official wording

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

Code information: Article No. 37882, Batch No. 96149; Article No. 37508, Batch No. 814929, 815096, 815140, and 855021.

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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