Z-2207-2020 Class II Terminated
FDA device recall Z-2207-2020 was initiated by Nobel Biocare Usa Llc on Jul 19, 2019 and is designated Class II. Reason for recall: The top label for dental implant may incorrectly indicate the implant length. Specifically, the label may contain 11.5mm for the length, which is shorter than the actual length of the implant (15mm)… The recall status is terminated (terminated Oct 27, 2020). Affected quantity: 221 implants.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 10, 2020
- Initiation Date
- Jul 19, 2019
- Termination Date
- Oct 27, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 221 implants
Product Description
NobelActive Internal NP 3.5x15mm Endosseus dental implant, REF: 34128, Rx Only, Sterile R, CE, UDI: (01)07332747010619
Reason for Recall
The top label for dental implant may incorrectly indicate the implant length. Specifically, the label may contain 11.5mm for the length, which is shorter than the actual length of the implant (15mm). An incorrect sized implant may cause patient discomfort, permanent nerve damage and may require an additional surgery.
Distribution Pattern
US: AL, AR, AZ, CA, CO, CT, FL, HI, ID, IL, IN, KY, MA, MS, MI, MO, NC, NH, NV, NY, OK, PA, SC, SD, TX, UT, WA, WI OUS: None
Code Information
Lot number: 13080792
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2207-2020
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026