Z-1853-2020 Class II Terminated
FDA device recall Z-1853-2020 was initiated by Nobel Biocare Usa Llc on Aug 9, 2019 and is designated Class II. Reason for recall: Packages of abutments may contain an incorrect screw. While the screw will tighten, it cannot be guaranteed that the screw will not loosen. In case the screw loosens the abutment should be retightened… The recall status is terminated (terminated Dec 1, 2021). Affected quantity: 239.
Recall Details
- Product Type
- Devices
- Report Date
- May 13, 2020
- Initiation Date
- Aug 9, 2019
- Termination Date
- Dec 1, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 239
Product Description
Temporary Abutment Engaging CC RP pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36664 - - 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.
Reason for Recall
Packages of abutments may contain an incorrect screw. While the screw will tighten, it cannot be guaranteed that the screw will not loosen. In case the screw loosens the abutment should be retightened with the correct screw.
Distribution Pattern
Worldwide distribution - US Nationwide distribution including in the states of AZ, AR, CA, CO, FL, GA, IL, IN, ID, KS, LA, MI, MD, ME, MA, MO, NY, NC, NJ, NE, NM, OH, OR, OK, PA, TX, TN, VA, WY, WA and WI. Countries of CA, CH, DE, ES, FR, GB, HU, IT, BR, CO, MX, CN, HK, IN, JP and TW.
Code Information
Catalog no. 36664, Lot no. 13077622, UDI: (01)07332747034301(10)13077622
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1853-2020
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026