Z-2250-2020 Class II Terminated
FDA device recall Z-2250-2020 was initiated by Nobel Biocare Usa Llc on May 28, 2019 and is designated Class II. Reason for recall: Packaged dental implant healing abutments were found to contain the wrong size device. The recall status is terminated (terminated Feb 9, 2021). Affected quantity: 234 pieces globally, of which 16 were sent to the US.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 10, 2020
- Initiation Date
- May 28, 2019
- Termination Date
- Feb 9, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 234 pieces globally, of which 16 were sent to the US.
Product Description
Healing Abutment Conical Connection RP 0 3.6 x 5mm, REF: 36644, UDI: 07332747034462 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function. The Healing Abutment is intended to be used as a temporary component to an endosseous implant to allow healing of the soft tissue.
Reason for Recall
Packaged dental implant healing abutments were found to contain the wrong size device.
Distribution Pattern
Worldwide distribution - US Nationwide distribution including in the states of TN, IL, MI, and NY. The countries of AT, RU, BE, DE, GB, NO, PL, PT.
Code Information
Lot 13076845
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2250-2020
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026