Summary
The FDA issued a Class II for Nobel Biocare N1 TiUltra TCC NP 3.5x13mm by Nobel Biocare. Reason: Due to the presence of a burr which may cause an aspiration risk to patient during surgical procedure..
Details
Source
Device Recall
External ID
Z-1565-2022
Action Date
2022-08-31
Status
Ongoing
Category
device
Product Description
Nobel Biocare N1 TiUltra TCC NP 3.5x13mm
Lot/Code Info: Catalog number: 300859 Lot numbers / UDI Codes: 12167337 / (01)07332747161717(10)12167337(11)210119(17)251218 12167830 / (01)07332747161717(10)12167830(11)210125(17)251224 12168184 / (01)07332747161717(10)12168184(11)210128(17)251227
Quantity Affected: 347 devices
Reason for Recall
Due to the presence of a burr which may cause an aspiration risk to patient during surgical procedure.
Distribution
U.S Nationwide.: AZ, CA, CT, FL, HI, NC, NY, OR, PA, TX, UT, and WI O.U.S.: Austria, Belgium, Canada, Germany, Spain, France, United Kingdom, Hungary, Iceland, Italy, Netherlands, Norway, Portugal, and Sweden
Type: Voluntary: Firm initiated
Recall Initiated: 2022-07-25
Company
Goteborg
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 194 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Nobel Biocare has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Nobel Biocare) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Nobel Biocare have FDA actions?
Nobel Biocare has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1565-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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