Z-1851-2020 Class II Terminated
FDA device recall Z-1851-2020 was initiated by Nobel Biocare Usa Llc on Aug 28, 2019 and is designated Class II. 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… The recall status is terminated (terminated Apr 28, 2021). Affected quantity: 228 pieces.
Recall Details
- Product Type
- Devices
- Report Date
- May 13, 2020
- Initiation Date
- Aug 28, 2019
- Termination Date
- Apr 28, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 228 pieces
Product Description
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 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 Pattern
International distribution - the country Russia only.
Code Information
Lot:12129104
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1851-2020
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026