Nobel Biocare Usa Llc: Temporary Abutment Engaging CC RP pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36664 - - Product Usage: Dental implant abutme

Is my product affected?

Temporary Abutment Engaging CC RP pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36664 - - 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 functio

• UPC 07332747034301

Check against the official notice below — it lists the full affected range.

What happened

Nobel Biocare USA LLC is recalling 239 Temporary Abutment Engaging CC RP pre-manufactured prosthetic components (catalog no. 36664, Lot no. 13077622) used in dental implant procedures. Packages of these abutments may contain an incorrect screw that, while able to tighten initially, cannot be guaranteed to remain secure and may loosen over time.

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 source document does not specify a remedy or what actions affected consumers should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

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: 239 Lot/code info: Catalog no. 36664, Lot no. 13077622, UDI: (01)07332747034301(10)13077622

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

• 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 funct2019-08-09
• 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.2019-08-09
• 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.2019-08-09
• 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 use2019-08-09
• 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 chew2019-08-09

All FDA (Device enforcement) recalls