Temporary Snap Abutment Engaging CC RP 1.5 mm; Pre-manufactured prosthetic components directly connected to the endosseous implant; catalog no. 38761 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chew
Check against the official notice below — it lists the full affected range.
Nobel Biocare USA LLC is recalling 478 Temporary Snap Abutment Engaging CC RP 1.5 mm dental implant components (catalog number 38761, lot numbers 13077550 and 13077551) because some packages may contain an incorrect screw. While the incorrect screw will initially tighten, it cannot be guaranteed that it will not loosen during use.
The affected products were distributed worldwide and throughout numerous U.S. states, as well as in Canada, Switzerland, Germany, Spain, France, the United Kingdom, Hungary, Italy, Brazil, Colombia, Mexico, China, Hong Kong, India, Japan, and Taiwan. The recall source does not specify a remedy for affected consumers.
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: 478 pieces Lot/code info: Catalog no.38761, Lot numbers 13077550 and 13077551; UDI: (01)07332747115604(10)13077550 and (01)07332747115604(10)13077551
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.