NobelReplace recallZ-2828-2020 · Nobel Biocare Services AG · initiated Jul 20, 2020
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Nobel Biocare Services AG or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-2828-2020
- Status
- Terminated
- Initiated by the company
- Jul 20, 2020
- Recalling firm
- Nobel Biocare Services AG
- Quantity
- 188
- Product code
- DZE
- FDA submissions
- K073142
- Distribution
- Worldwide distribution - U.S. Nationwide distribution including in the states of FL and NY and the countries of Albania and Hong Kong.
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.
Code information (models, lots, serial numbers)
Lot: 13084072, UDI: (01)07332747073584(10)13084072(17)240525
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- NobelReplace® 37291Nobel Biocare AB · IMPLANT, ENDOSSEOUS, ROOT-FORM1 recall715 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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