Device 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.
Z-2828-2020
Product summary
- Event
- Event 86085
- Status
- Terminated
- Classification
- Class II
- Quantity
- 188
- Official record key
device-enforcement:Z-2828-2020
Official wording
Reason: 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.
Code information: Lot: 13084072, UDI: (01)07332747073584(10)13084072(17)240525
Distribution pattern: Worldwide distribution - U.S. Nationwide distribution including in the states of FL and NY and the countries of Albania and Hong Kong.
Derived failure modes
-
Unknown
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.