Z-2828-2020 Class II Terminated
FDA device recall Z-2828-2020 was initiated by NOBEL BIOCARE SERVICES AG on July 20, 2020 and is designated Class II. 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 sur… The recall status is terminated (terminated May 12, 2021). Affected quantity: 188.
Recall Details
- Product Type
- Devices
- Report Date
- August 26, 2020
- Initiation Date
- July 20, 2020
- Termination Date
- May 12, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 188
Product Description
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 Pattern
Worldwide distribution - U.S. Nationwide distribution including in the states of FL and NY and the countries of Albania and Hong Kong.
Code Information
Lot: 13084072, UDI: (01)07332747073584(10)13084072(17)240525