FDAClass IIJune 10, 2020

Healing Abutment Conical Connection RP 0 3.6 x 5mm recall

Healing Abutment Conical Connection RP 0 3.6 x 5mm, REF: 36644, UDI: 07332747034462 - Product Usage: Dental implant abutments are intended to be used…

Why was Healing Abutment Conical Connection RP 0 3.6 x 5mm recalled?

Packaged dental implant healing abutments were found to contain the wrong size device.

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?

Lot 13076845

Product
Healing Abutment Conical Connection RP 0 3.6 x 5mm, REF: 36644, UDI: 07332747034462 - Product Usage: Dental implant abutments are intended to be used…
Recalling firm
Nobel Biocare Usa Llc
Quantity
234 pieces globally, of which 16 were sent to the US.
Distribution
Worldwide distribution - US Nationwide distribution including in the states of TN, IL, MI, and NY. The countries of AT, RU, BE, DE, GB, NO, PL, PT.
Recall date
June 10, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls