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U.S. Department of Health and Human Services

Class 2 Device Recall Abutment Screw Retrieval Kit

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  Class 2 Device Recall Abutment Screw Retrieval Kit see related information
Date Initiated by Firm March 14, 2019
Create Date February 19, 2020
Recall Status1 Completed
Recall Number Z-1324-2020
Recall Event ID 84450
510(K)Number K955697  
Product Classification Implant, endosseous, root-form - Product Code DZE
Product Abutment Screw Retrieval Kit - Product Usage: The kit itself does not have a specific intended Use, but included devices have specific intended use as shown above.
Code Information (01)07332747083866(10)818727 (01)07332747083866(10)818683  Catalog# 37481
Recalling Firm/
Manufacturer
Nobel Biocare Usa Llc
22715 Savi Ranch Pkwy
Yorba Linda CA 92887-4609
For Additional Information Contact
714-282-4800
Manufacturer Reason
for Recall
Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
FDA Determined
Cause 2
Packaging process control
Action On 3/27/2018 the firm issued a recall notice by email to affected consignees. The recall notification informed the following actions to be taken by the consignees: 1. Identify affected devices as detailed in the Customer Reply Form. 2. Do not use affected devices. 3. Send back the Customer Reply Form and the affected devices. The firm will replace affected devices free of charge. This letter needs to be passed on to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. We kindly ask you to follow instructions provided in this Recall Letter and return the attached Customer Reply Form to the firm via email or fax at 714- 282-5073.
Quantity in Commerce 7 units
Distribution Worldwide distribution - US Nationwide distribution and countries of CA, AU, JP, BR, ZA, RU, TW, HK, IN, CN, SA, NZ, MO, CO, LB, AT, BE, CH, CY, DE, DK, EE, ES, FI, FR, GB, GG, GR, HR, HU, IE, LT, LU, NL, PL, PT, RS, SE.
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.
510(K) Database 510(K)s with Product Code = DZE and Original Applicant = NOBELPHARMA USA, INC.
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