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.
- 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
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.