Class 2 Device Recall NobelReplace Hexagonal Implant

• Date Initiated by Firm: July 20, 2020
• Create Date: August 20, 2020
• Recall Status: Terminated on May 12, 2021
• Recall Number: Z-2828-2020
• Recall Event ID: 86085
• 510(K)Number: K073142
• Product Classification: Implant, endosseous, root-form - Product Code DZE
• 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.
• Code Information: Lot: 13084072, UDI: (01)07332747073584(10)13084072(17)240525
• Recalling Firm/ Manufacturer: NOBEL BIOCARE SERVICES AG; Balz-zimmermannstrasse 7; Kloten Switzerland
• Manufacturer 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.
• FDA Determined Cause: Process control
• Action: On 07/20/20, Urgent Medical Device Recall notices were emailed to customers who were asked to do the following: 1. Inspect your stock and confirm that both the cap label and the vial label indicate 4.3x10mm. 2. Quarantine devices with cap label 5.0x8mm. 3. Complete attached Customer Acknowledgment Form, even if you do not have any affected stock, and return it to the recalling firm via email. 4. Return all incorrectly labeled devices to the firm. Correctly labeled devices do not need to be returned. 5. Ensure relevant staff members are informed of this recall. If you have supplied or transferred any potentially affected product to another facility or organization, let that facility know of the recall by providing a copy of this letter. 6. Firm will replace returned affected devices. If you require any further information or support, please contact your local customer support representative at 714-282-4800 ext. 1527.
• Quantity in Commerce: 188
• Distribution: Worldwide distribution - U.S. Nationwide distribution including in the states of FL and NY and the countries of Albania and Hong Kong.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DZE