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U.S. Department of Health and Human Services

Class 2 Device Recall Nobel Biocare N1 TiUltra TCC NP 3.5x13mm

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 Class 2 Device Recall Nobel Biocare N1 TiUltra TCC NP 3.5x13mmsee related information
Date Initiated by FirmJuly 25, 2022
Date PostedAugust 23, 2022
Recall Status1 Open3, Classified
Recall NumberZ-1565-2022
Recall Event ID 90679
510(K)NumberK211109 
Product Classification Implant, endosseous, root-form - Product Code DZE
ProductNobel Biocare N1 TiUltra TCC NP 3.5x13mm
Code Information Catalog number: 300859 Lot numbers / UDI Codes: 12167337 / (01)07332747161717(10)12167337(11)210119(17)251218 12167830 / (01)07332747161717(10)12167830(11)210125(17)251224 12168184 / (01)07332747161717(10)12168184(11)210128(17)251227
Recalling Firm/
Manufacturer		 Nobel Biocare
Vastra Hamngatan 1
Goteborg Sweden
Manufacturer Reason
for Recall		Due to the presence of a burr which may cause an aspiration risk to patient during surgical procedure.
FDA Determined
Cause 2		Process change control
ActionOn 07/25/2022, Nobel Biocare AB sent an "URGENT MEDICAL DEVICE RECALL" Letter via UPS to customers informing them that there may be a burr present on the co-packed OsseoShaper 1 around the waist of the device. The hazard is primarily identified as a risk of the patient swallowing or inhaling the burr if it comes loose from the OsseoShaper 1 during the clinical procedure. Customer are instructed to: 1. Inspect their stock and quarantine affected devices. 2. Complete attached Customer Acknowledgment Form, even if they do not have any affected stock, and return it to Nobel Biocare, via email to us.cs.complaints@nobelbiocare.com or fax 714-282-5073 within 5 days of receipt of this notice. 3. Return all affected stock on hand to Nobel Biocare using the shipping label attached to this notice. 4. Ensure relevant staff members are informed of this recall. If they 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 notice. Nobel Biocare has implemented preventive actions and will replace devices subject to this recall free of charge. For questions - contact local customer support representative at 800-322-5001 ext. 1527.
Quantity in Commerce347 devices
DistributionU.S Nationwide.: AZ, CA, CT, FL, HI, NC, NY, OR, PA, TX, UT, and WI O.U.S.: Austria, Belgium, Canada, Germany, Spain, France, United Kingdom, Hungary, Iceland, Italy, Netherlands, Norway, Portugal, and Sweden
Total Product Life CycleTPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = DZE
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