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U.S. Department of Health and Human Services

Class 2 Device Recall Abutment Screw Retrieval Instrument 3.0/NP

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  Class 2 Device Recall Abutment Screw Retrieval Instrument 3.0/NP see related information
Date Initiated by Firm March 14, 2019
Create Date February 19, 2020
Recall Status1 Completed
Recall Number Z-1322-2020
Recall Event ID 84450
Product Classification Accessories, implant, dental, endosseous - Product Code NDP
Product Abutment Screw Retrieval Instrument 3.0/NP - Product Usage: The instruments for abutment screw retrieval can be used if an abutment screw is broken and a part of the screw is left inside the implant screw channel. If the implant thread needs to be cleaned before placing a new screw, a screw tap repair can be used. The instruments are intended for both simple and advanced treatments.
Code Information (01)07332747084085(10)73585 (01)07332747084085(10)73430 Catalog # 37503 
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 233 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.
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