Temporary Abutment Non-Engaging CC RP pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36662 - 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 funct
Check against the official notice below — it lists the full affected range.
Nobel Biocare USA LLC is recalling 236 units of Temporary Abutment Non-Engaging CC RP pre-manufactured prosthetic components (catalog number 36662, lot number 13078005) distributed worldwide. Packages of these dental implant abutments may contain an incorrect screw that, while it will tighten, cannot be guaranteed not to loosen over time.
If the screw loosens, the abutment should be retightened with the correct screw. The recall notice does not specify a remedy or instructions for affected consumers to obtain replacement products or additional information.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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: 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. Quantity: 236 Lot/code info: Catalog no. 36662, Lot no. 13078005, UDI: (01)07332747034301(10)13078005
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.