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U.S. Department of Health and Human Services

Class 2 Device Recall NobelReplace CC RP 4.3x11.5 mm

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  Class 2 Device Recall NobelReplace CC RP 4.3x11.5 mm see related information
Date Initiated by Firm December 17, 2021
Create Date February 18, 2022
Recall Status1 Open3, Classified
Recall Number Z-0658-2022
Recall Event ID 89465
510(K)Number K073142  
Product Classification Implant, endosseous, root-form - Product Code DZE
Product NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R
Code Information Catalog Number: 36707 UDI Code: (01)07332747160529(10)13116495(11)210720(17)260618; (01)07332747160529(10)13116496(11)210720(17)260618; (01)07332747160529(10)13116497(11)210720(17)260618; Lot Numbers: 13116495, 13116496, 13116497
Recalling Firm/
Manufacturer		 Nobel Biocare Usa Llc
22715 Savi Ranch Pkwy
Yorba Linda CA 92887-4609
For Additional Information Contact Bryan Sowtzke
608-828-5223
Manufacturer Reason
for Recall		 Due to 16 complaints related to drivers not engaging in implants. According to the firm's investigations, the incorrect offset gauge was potentially used during production of the implants. As a result, this could potentially lead to aborted or a delay in surgical procedure.
FDA Determined
Cause 2		 Under Investigation by firm
Action On 01/12/2022, the firm sent an "URGENT MEDICAL DEVICE RECALL" Letter via UPS to customers informing them that specific batches/lots of devices, the dimensions of the hexagon connection part are potentially not fully conforming to specification and may not fully engage in the implant. Customers are instructed to: 1. Inspect their stock and quarantine all affected devices. 2. Complete the Customer Acknowledgement Form and return to the Recalling Firm via email or fax within 5 days of receipt of this notice. 3. Return all affected stock on hand to the Recalling Firm using the shipping label provided. 4. Ensure relevant staff members are informed of this recall, and if you further supplied or transferred any of the affected products to another facility or organization, let these facilities know of the recall and provide them with a copy of this notice. For questions, contact your local customer support representative,
Quantity in Commerce 702 pieces
Distribution Worldwide distribution - U.S. Nationwide distribution in the states of AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, MA, ME, MI, MN, MS, NC, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA and WI. The countries of Canada, Mexico and Turkey.
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 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) Database 510(K)s with Product Code = DZE and Original Applicant = NOBEL BIOCARE USA LLC
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