Z-1851-2020Class II

NobelParallel Conical Connection NP, 3.75x10mm (Endosseous Dental Implant); REF 37965; UDI...

Name: Z-1851-2020 NobelParallel Conical Connection NP, 3.75x10mm (Endosseous Dental Implant); REF 37965; UDI...
Creator: Nobel Biocare Usa Llc
Published: 2019-08-28
License: https://open.fda.gov/license/

Nobel Biocare USA LLC / initiated 2019-08-28 / Terminated / root cause: labeling and UDI

FDA source

Nobel Biocare Usa Llc began a recall of NobelParallel Conical Connection NP, 3.75x10mm (Endosseous Dental Implant); REF 37965; UDI (01)07332747091441(10)12129104(17)240203 - Product Usage: are... on 2019-08-28. FDA classified it as Class II and gives the reason as "The top label of article no. 37965, lot 12129104 (immediate packaging of endosseous dental implants ) may incorrectly indicate an implant length of 7mm, which is shorter than the actual length of the implant (10mm)". 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-1851-2020
Classification: Class II
Status: Terminated
Initiated: 2019-08-28
Posted: 2020-05-04
Terminated: 2021-04-28
Recalling firm: Nobel Biocare USA LLC
Product: NobelParallel Conical Connection NP, 3.75x10mm (Endosseous Dental Implant); REF 37965; UDI (01)07332747091441(10)12129104(17)240203 - Product Usage: are intended to be used in the upper or lower jaw bone (osseointegration) and used for anchoring or supporting tooth replacements to restore chewing function.
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: The top label of article no. 37965, lot 12129104 (immediate packaging of endosseous dental implants ) may incorrectly indicate an implant length of 7mm, which is shorter than the actual length of the implant (10mm).
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: The firm's "Urgent Field Safety Notice", was issued on 08/28/2019 and the notices were sent to customers via email . The following actions are to be taken: 1) Identify affected devices in stock by confirming the information on the side label: 3.75x10mm, article no. 37965, lot 12129104. 2) Confirm that both the side and top label indicate 3.75x10mm. 3) Complete a Customer Acknowledgment Form and return it via email to: [email protected] within 5 days of receipt of the notice. 4) Return incorrectly labeled products (top label 3.75x7mm) to: Attn: Returns PFA1925 109004 Moscow Stanislavskogo str., h.21, b.3 (Correctly labeled products (top label 3.75x 10mm) do not need to be returned). 5) Returned devices will be replaced free of charge.
Quantity in commerce: 228 pieces
Distribution: International distribution - the country Russia only.
Product codes and lots: Lot:12129104

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1851-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1851-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-13	2020-05-04

Product code DZE

K173418Class IINobelParallel Conical ConnectionNobel Biocare AB / cleared 2019-02-21

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)