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.
FDA Recall Z-1851-2020 · Posted 2020-05-04
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Recalling FirmNobel Biocare Usa Llc
Recall StatusTerminated
Product CodeDZE
Date Initiated2019-08-28
Date Terminated2021-04-28
Product Quantity228 pieces
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).
Firm 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.
Root Cause
Labeling mix-ups
Distribution Pattern
International distribution - the country Russia only.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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