NobelReplace Conical Connection (CC) PMC RP 4.3x10mm, REF: 37291 - Product Usage: implants are intended to be used in the upper or lower jaw bone (osseointegration) and used for anchoring or supporting tooth replacements to restore chewing function.
Check against the official notice below — it lists the full affected range.
Nobel Biocare Services AG is recalling 188 NobelReplace Conical Connection (CC) PMC RP dental implants (Lot 13084072) due to labeling errors. The implant caps are labeled with incorrect measurements of 5.0x8mm when the actual implant measurements are 4.3x10mm. If a dentist does not notice this discrepancy before placing the implant, it could result in complications including the need for a second surgical procedure, implant replacement, or in cases where the implant is placed in the posterior lower jaw, potential damage to the inferior alveolar nerve canal or perforation of a small artery requiring immediate removal.
The affected implants were distributed worldwide, including throughout the United States (specifically in Florida and New York) as well as in Albania and Hong Kong. The recall document does not specify a remedy for consumers who may have received these implants.
Written by software from the official notice below. Not reviewed by a lawyer.
Dental implant cap label may incorrectly indicate implant measurements 5.0x8mm. Actual implant measurements are 4.3x10mm. If not noticed prior to implant placement, this could lead to: 1) A second surgical procedure; 2) Implant replacement; 3) If placed in posterior lower jaw, the implant may damage the inferior alveolar nerve canal or perforate a small artery requiring immediate implant removal.
Reason for recall: Dental implant cap label may incorrectly indicate implant measurements 5.0x8mm. Actual implant measurements are 4.3x10mm. If not noticed prior to implant placement, this could lead to: 1) A second surgical procedure; 2) Implant replacement; 3) If placed in posterior lower jaw, the implant may damage the inferior alveolar nerve canal or perforate a small artery requiring immediate implant removal. Distribution: Worldwide distribution - U.S. Nationwide distribution including in the states of FL and NY and the countries of Albania and Hong Kong. Quantity: 188 Lot/code info: Lot: 13084072, UDI: (01)07332747073584(10)13084072(17)240525
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.