Dense Bone Drill NP 3.5x16 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement.
Check against the official notice below — it lists the full affected range.
Nobel Biocare USA LLC is recalling Dense Bone Drill NP 3.5x16 mm Single-Pat devices used to prepare bone in the upper and lower jaw prior to implant placement. The recall was initiated because a problem with the packaging sealing process at the supplier means the sterilized drills cannot be guaranteed to remain sterile throughout their shelf-life.
The affected devices were distributed worldwide, including throughout the United States and in Canada, Australia, Japan, Brazil, South Africa, Russia, Taiwan, Hong Kong, India, China, Saudi Arabia, New Zealand, Macau, Colombia, Lebanon, Austria, Belgium, Switzerland, Cyprus, Germany, Denmark, Estonia, Spain, Finland, France, the United Kingdom, Guernsey, Greece, Croatia, Hungary, Ireland, Lithuania, Luxembourg, the Netherlands, Poland, Portugal, Serbia, and Sweden. The product recall record does not specify a remedy or actions affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
Reason for recall: Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life. Distribution: Worldwide distribution - US Nationwide distribution and countries of CA, AU, JP, BR, ZA, RU, TW, HK, IN, CN, SA, NZ, MO, CO, LB, AT, BE, CH, CY, DE, DK, EE, ES, FI, FR, GB, GG, GR, HR, HU, IE, LT, LU, NL, PL, PT, RS, SE. Quantity: None Lot/code info: (01)07332747065480(10)73574 Catalog# 37095
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.