FDAClass IIJuly 22, 2015

Abutment Retrieval Instrument Zirconia CC RP/WP recall

Abutment Retrieval Instrument Zirconia CC RP/WP, Article No. 37882 and Abutment Retrieval Kit, Article No. 37508 (Article No. 37882 was assembled in…

Why was Abutment Retrieval Instrument Zirconia CC RP/WP recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Abutment Retrieval Instrument Zirconia CC RP/WP, Article No. 37882 and Abutment Retrieval Kit, Article No. 37508 (Article No. 37882 was assembled in…
Recalling firm
Nobel Biocare Usa Llc
Quantity
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.
Recall date
July 22, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
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