Nobel Biocare Usa Llc: Temporary Snap Abutment Engaging CC RP 1.5 mm; Pre-manufactured prosthetic components directly connected to the endosseous implant; catalog no. 38761 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function.

Recall number

Z-1857-2020

Recalling firm

Nobel Biocare Usa Llc

Product

Temporary Snap Abutment Engaging CC RP 1.5 mm; Pre-manufactured prosthetic components directly connected to the endosseous implant; catalog no. 38761 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function.

Status

Terminated

Initiated

2019-08-09

Posted

not on file

Terminated

2021-12-01

Reason

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.

Root cause

Process control

Action

Urgent Medical Device Recall Letters were sent to U.S. customers via the U.S Postal Service and OUS customers via email beginning on August 9, 2019. This communication notified customers that the firm had identified a packaging issue affecting six product codes and a total of 7 lots of medical devices (titanium abutments) where the packages of abutment lots may contain an incorrect screw. Customers were informed that while the screw will tighten, it cannot be guaranteed that the screw will not loosen. If the screw loosens, customers are instructed to retighten the abutment with the correct screw. Customers were requested to: i1) identify all devices of the affected lots which they have in stock, 2) not to use the affected devices, 3) complete the Customer Acknowledgement Form and, 4) return it to Nobel Biocare via email at us.complaints@nobelbiocare.com or by fax to 714-282-5073, within 5 days of receipt of the Urgent Medical Device Recall Letter. Customers were instructed to return all devices from affected lots to Nobel Biocare, Attn: Returns PFA1914, 22715 Savi Ranch Parkway, Yorba Linda, CA 92887. The Urgent Medical Device Recall Letter notes that the manufacturer has reviewed the packaging process, has implemented corrective actions and will initiate preventive actions. The letter requests that customers pass the letter on to all those who need to be aware within their organizations or to any organization where the potentially affected devices have been transferred. Customers were instructed to contact their customer support representative at 1-800-322-5001, ext. 1527, if they require further information or support.

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.

Lot, serial or model codes

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

510(k) numbers

["K161435"]

PMA numbers

not on file

Product code

NHA

Firm FEI

1000125598

Firm city

Yorba Linda

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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