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U.S. Department of Health and Human Services

Class 2 Device Recall NobelParallel Conical Connection

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 Class 2 Device Recall NobelParallel Conical Connectionsee related information
Date Initiated by FirmAugust 28, 2019
Date PostedMay 04, 2020
Recall Status1 Terminated 3 on April 28, 2021
Recall NumberZ-1851-2020
Recall Event ID 85236
510(K)NumberK173418 
Product Classification Implant, endosseous, root-form - Product Code DZE
ProductNobelParallel 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.
Code Information Lot:12129104
Recalling Firm/
Manufacturer		 Nobel Biocare Usa Llc
22715 Savi Ranch Pkwy
Yorba Linda CA 92887-4609
For Additional Information ContactOxana Bulakova
714-282-4800
Manufacturer 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).
FDA Determined
Cause 2		Labeling mix-ups
ActionThe 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: cs.russia@nobelbiocare.com 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 Commerce228 pieces
DistributionInternational distribution - the country Russia only.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DZE
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