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Class 2 Device Recall NobelActive Internal Connection Implant |
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Date Initiated by Firm |
July 19, 2019 |
Create Date |
June 03, 2020 |
Recall Status1 |
Terminated 3 on October 27, 2020 |
Recall Number |
Z-2207-2020 |
Recall Event ID |
85331 |
510(K)Number |
K071370
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Product Classification |
Abutment, implant, dental, endosseous - Product Code NHA
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Product |
NobelActive Internal NP 3.5x15mm Endosseus dental implant, REF: 34128, Rx Only, Sterile R, CE, UDI: (01)07332747010619 |
Code Information |
Lot number: 13080792 |
Recalling Firm/ Manufacturer |
Nobel Biocare Usa Llc 22715 Savi Ranch Pkwy Yorba Linda CA 92887-4609
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For Additional Information Contact |
Nobel Biocare 1800-322-5001 Ext. 1527
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Manufacturer Reason for Recall |
The top label for dental implant may incorrectly indicate the implant length. Specifically, the label may contain 11.5mm for the length, which is shorter than the actual length of the implant (15mm). An incorrect sized implant may cause patient discomfort, permanent nerve damage and may require an additional surgery.
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FDA Determined Cause 2 |
Labeling mix-ups |
Action |
Customers who received product/affected lot were to be contacted via Urgent Medical Device Recall Letter dated July 18, 2019 via USPS on July 19, 2019. In addition to informing customers about the recall, the recall notification asked customer to take the following actions:
1. Identify affected devices in your stock by confirming the information on the side label: NobelActive Internal NP 3.5x15mm, article 34128, lot 13080792.
2. Confirm the information on the top label as shown in figure 1 above.
3. Complete attached Customer Acknowledgment Form and return it to Nobel Biocare, via email to us.complaints@nobelbiocare.com or fax 714-282-5073, within 5 days of receipt of this letter.
4. Return incorrectly labeled products (top label 3.5x11.5) to: Nobel Biocare
Attn: Returns PFA1917
22715 Savi Ranch Pkwy
Yorba Linda, CA 92887 .
5. Correctly labeled products (top label 3.5x15) do not need to be returned.
6. If you require any further information or support, please contact your customer support representative at 1-800-322- 5001 x.1527. |
Quantity in Commerce |
221 implants |
Distribution |
US: AL, AR, AZ, CA, CO, CT, FL, HI, ID, IL, IN, KY, MA, MS, MI, MO, NC, NH, NV, NY, OK, PA, SC, SD, TX, UT, WA, WI
OUS: None |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = NHA and Original Applicant = NOBEL BIOCARE AB
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