Reported Jul 22, 2015 · Terminated

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

Nobel Biocare USA LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Nobel Biocare Usa Llc · 22715/22725 Savi Ranch Pkwy · Yorba Linda, CA · 92887

Is this the product you have?

  • 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.
Lot codes and dates
    • Article No. 37882
    • Batch No. 96149
    • Article No. 37508
    • Batch No. 814929
    • 815096
    • 815140
    • and 855021
Amount recalled
149 units total

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 18, 2015 · Data as of Sep 19, 6:14 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.