FDA Device recall Z-1851-2020
NobelParallel Conical Connection NP, 3.75x10mm (Endosseous Dental Implant)
- FDA Device
- Class II
- terminated
- Published 2020-05-13
On 2020-05-13 the FDA classified a Class II recall of NobelParallel Conical Connection NP, 3.75x10mm (Endosseous Dental Implant) by Nobel Biocare Usa, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1851-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-08-28 |
| Published | 2020-05-13 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Nobel Biocare Usa |
| Distribution | n/a |
Product
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.
Reason
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).
Identifiers
| code_info | Lot:12129104 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1851-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.