NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R
Summary
The FDA issued a Class II for NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R by Nobel Biocare Usa Llc. Reason: Due to 16 complaints related to drivers not engaging in implants. According to the firm's investigations, the incorrect offset gauge was potentially .
Details
Source
Device Recall
External ID
Z-0658-2022
Action Date
2022-03-02
Status
Terminated
Category
device
Product Description
NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R
Lot/Code Info: Catalog Number: 36707 UDI Code: (01)07332747160529(10)13116495(11)210720(17)260618; (01)07332747160529(10)13116496(11)210720(17)260618; (01)07332747160529(10)13116497(11)210720(17)260618; Lot Numbers: 13116495, 13116496, 13116497
Quantity Affected: 702 pieces
Reason for Recall
Due to 16 complaints related to drivers not engaging in implants. According to the firm's investigations, the incorrect offset gauge was potentially used during production of the implants. As a result, this could potentially lead to aborted or a delay in surgical procedure.
Distribution
Worldwide distribution - U.S. Nationwide distribution in the states of AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, MA, ME, MI, MN, MS, NC, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA and WI. The countries of Canada, Mexico and Turkey.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-12-17
Company
Yorba Linda, CA
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 122 device recalls issued in the same week, part of 403 device-related FDA actions this month.
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 Usa Llc) 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 Usa Llc have FDA actions?
This is the only FDA action we have on record for Nobel Biocare Usa Llc in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0658-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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