Universal Base CC RP 1.5 mm; The Universal Base Abutment in combination with Nobel Biocare end osseous implants are indicated for single-unit if screw retained and for multiple-unit if cement retained crowns are used; catalog no. 38214 - Product Usage: Dental implant abutments are intended to be use
Check against the official notice below — it lists the full affected range.
Nobel Biocare USA is recalling 238 pieces of Universal Base CC RP 1.5 mm abutments used with dental implants because the packages may contain an incorrect screw. While the incorrect screw can be tightened initially, it cannot be guaranteed that it will not loosen over time. The affected lot is catalog number 38214, lot number 13076822. The product was distributed worldwide and throughout numerous U.S. states, as well as in Canada, Switzerland, Germany, Spain, France, United Kingdom, Hungary, Italy, Brazil, Colombia, Mexico, China, Hong Kong, India, Japan, and Taiwan.
If the screw loosens on an affected abutment, it should be retightened with the correct screw. The recall record does not specify a remedy or instructions for consumers to obtain replacement screws or products.
Written by software from the official notice below. Not reviewed by a lawyer.
Packages of abutments (universal base) 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 (universal base) 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: 238 pieces Lot/code info: Catalog no. 38214, Lot no. 13076822, UDI: (01)07332747096538(10)13076822
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.