Esthetic Abutment CC RP 1.5 mm pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36669 - 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.
Check against the official notice below — it lists the full affected range.
Nobel Biocare USA LLC is recalling 227 units of Esthetic Abutment CC RP 1.5 mm dental implant abutments (catalog no. 36669, lot no. 13077560) distributed worldwide and throughout the United States. The affected packages may contain an incorrect screw that, while it will tighten, cannot be guaranteed to remain secure and may loosen over time.
If the abutment screw loosens, it should be retightened with the correct screw. The recall notice does not specify what actions affected consumers should take.
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: 227 pieces Lot/code info: Catalog no. 36669, Lot no. 13077560, UDI: (01)07332747032598(10)13077560
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.