NobelParallel Conical Connection NP, 3.75x10mm (Endosseous Dental Implant); REF 37965; UDI (01)07332747091441(10)1212910
FDA device recall Z-1851-2020 · posted 2020-05-04 · Terminated
Recall details
- Recalling firm
- Nobel Biocare Usa Llc
- 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).
- 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.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- DZE
- Quantity affected
- 228 pieces
- Distribution
- International distribution - the country Russia only.
- Date initiated
- 2019-08-28
- Date posted
- 2020-05-04
- Date terminated
- 2021-04-28
- Location
- Yorba Linda, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NobelParallel Conical Connection (K173418) | Nobel Biocare AB | 2019-02-21 |