FDAClass IIMay 13, 2020

Temporary Snap Abutment Engaging CC RP 1.5 mm recall

Temporary Snap Abutment Engaging CC RP 1.5 mm; Pre-manufactured prosthetic components directly connected to the endosseous implant; catalog no. 38761…

Why was Temporary Snap Abutment Engaging CC RP 1.5 mm recalled?

Packages of abutments may contain an incorrect screw. While the screw will tighten, it cannot be guaranteed that the screw will not loosen. In case the screw loosens the abutment should be retightened with the correct screw.

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?

Catalog no.38761, Lot numbers 13077550 and 13077551; UDI: (01)07332747115604(10)13077550 and (01)07332747115604(10)13077551

Product
Temporary Snap Abutment Engaging CC RP 1.5 mm; Pre-manufactured prosthetic components directly connected to the endosseous implant; catalog no. 38761…
Recalling firm
Nobel Biocare Usa Llc
Quantity
478 pieces
Distribution
Worldwide distribution - US Nationwide distribution including in the states of AZ, AR, CA, CO, FL, GA, IL, IN, ID, KS, LA, MI, MD, ME, MA, MO, NY, NC, NJ, NE, NM, OH, OR, OK, PA, TX, TN, VA, WY, WA and WI. Countries of CA, CH, DE, ES, FR, GB, HU, IT, BR, CO, MX, CN, HK, IN, JP and TW.
Recall date
May 13, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
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