Z-2207-2020Class II

NobelActive Internal NP 3.5x15mm Endosseus dental implant, REF: 34128, Rx Only, Sterile R, CE, UDI...

Name: Z-2207-2020 NobelActive Internal NP 3.5x15mm Endosseus dental implant, REF: 34128, Rx Only, Sterile R, CE, UDI...
Creator: Nobel Biocare Usa Llc
Published: 2019-07-19
License: https://open.fda.gov/license/

Nobel Biocare USA LLC / initiated 2019-07-19 / Terminated / root cause: labeling and UDI

FDA source

Nobel Biocare Usa Llc began a recall of NobelActive Internal NP 3.5x15mm Endosseus dental implant, REF: 34128, Rx Only, Sterile R, CE, UDI: (01)07332747010619 on 2019-07-19. FDA classified it as Class II and gives the reason as "The top label for dental implant may incorrectly indicate the implant length. Specifically, the label may contain 11.5mm for the length, which is shorter than the actual length of the implant (15mm). An incorrect sized...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2207-2020
Classification: Class II
Status: Terminated
Initiated: 2019-07-19
Posted: 2020-06-03
Terminated: 2020-10-27
Recalling firm: Nobel Biocare USA LLC
Product: NobelActive Internal NP 3.5x15mm Endosseus dental implant, REF: 34128, Rx Only, Sterile R, CE, UDI: (01)07332747010619
Product code: NHA Abutment, Implant, Dental, Endosseous
Reason for recall: The top label for dental implant may incorrectly indicate the implant length. Specifically, the label may contain 11.5mm for the length, which is shorter than the actual length of the implant (15mm). An incorrect sized implant may cause patient discomfort, permanent nerve damage and may require an additional surgery.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Customers who received product/affected lot were to be contacted via Urgent Medical Device Recall Letter dated July 18, 2019 via USPS on July 19, 2019. In addition to informing customers about the recall, the recall notification asked customer to take the following actions: 1. Identify affected devices in your stock by confirming the information on the side label: NobelActive Internal NP 3.5x15mm, article 34128, lot 13080792. 2. Confirm the information on the top label as shown in figure 1 above. 3. Complete attached Customer Acknowledgment Form and return it to Nobel Biocare, via email to [email protected] or fax 714-282-5073, within 5 days of receipt of this letter. 4. Return incorrectly labeled products (top label 3.5x11.5) to: Nobel Biocare Attn: Returns PFA1917 22715 Savi Ranch Pkwy Yorba Linda, CA 92887 . 5. Correctly labeled products (top label 3.5x15) do not need to be returned. 6. If you require any further information or support, please contact your customer support representative at 1-800-322- 5001 x.1527.
Quantity in commerce: 221 implants
Distribution: US: AL, AR, AZ, CA, CO, CT, FL, HI, ID, IL, IN, KY, MA, MS, MI, MO, NC, NH, NV, NY, OK, PA, SC, SD, TX, UT, WA, WI OUS: None
Product codes and lots: Lot number: 13080792

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2207-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2207-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-10	2020-06-02

Product code NHA

K071370Class IINobelactive Internal Connection ImplantNobel Biocare AB / cleared 2007-08-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)