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U.S. Department of Health and Human Services

Class 2 Device Recall Implant Retrieval Instrument CC NP & Ext Hex WP 22 mm

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  Class 2 Device Recall Implant Retrieval Instrument CC NP & Ext Hex WP 22 mm see related information
Date Initiated by Firm March 14, 2019
Date Posted February 19, 2020
Recall Status1 Terminated 3 on February 15, 2024
Recall Number Z-1319-2020
Recall Event ID 84450
Product Classification Accessories, implant, dental, endosseous - Product Code NDP
Product Implant Retrieval Instrument CC NP & Ext Hex WP 22 mm - Product Usage: They can be used to remove implants, if the implant connection has been damaged. It can be used to remove implants with internal conical connection, internal tri-channel connection or external hex connection.
Code Information (01)07332747083798(10)73614 (01)07332747083798(10)73256 Catalog# 37474          
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 423 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.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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