Snappy Abutment 5.5 CC RP 3 mm; pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36683 - - 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 Snappy Abutment 5.5 CC RP 3 mm dental implant abutments (catalog number 36683, lot number 13077700) because some packages may contain an incorrect screw. While the incorrect screw can be tightened, it cannot be guaranteed that it will not loosen after installation. A total of 215 pieces have been 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.
If the screw loosens on an installed abutment, it should be retightened with the correct screw. The recall source does not specify what actions an affected consumer should take beyond this guidance.
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: 215 pieces Lot/code info: Catalog no. 36683, Lot no. 13077700, UDI: (01)07332747034264(10)13077700
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.