medical Class II Updated 2020-08-26

NOBEL BIOCARE SERVICES AG recalls NobelReplace Conical Connection (CC) PMC RP 4.3x10mm, REF: 3

Recalled Product

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.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot: 13084072, UDI: (01)07332747073584(10)13084072(17)240525
View official government recall

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