FDA recall Z-2828-2020

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.

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.

Key facts

Status

Terminated

Initiation date

2020-07-20

Report date

2020-08-26

Termination date

2021-05-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Kloten, N/A, Switzerland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2828-2020