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.
This recall has been terminated (originally issued May 4, 2020).
- Company
- Nobel Biocare Usa Llc
- Recall Initiated
- August 28, 2019
- Posted
- May 4, 2020
- Terminated
- April 28, 2021
- Recall Number
- Z-1851-2020
- Quantity
- 228 pieces
- Firm Location
- Yorba Linda, CA
- Official Source
- View on FDA website ↗
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).
Distribution
International distribution - the country Russia only.
Lot / Code Info
Lot:12129104
Root Cause
Labeling mix-ups
Action Taken
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: 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.