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U.S. Department of Health and Human Services

Class 2 Device Recall RePlant Angled Abutment Part Number 60505260

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  Class 2 Device Recall RePlant Angled Abutment Part Number 60505260 see related information
Date Initiated by Firm July 05, 2016
Date Posted August 02, 2016
Recall Status1 Terminated 3 on February 16, 2017
Recall Number Z-2320-2016
Recall Event ID 74624
510(K)Number K061319  
Product Classification Implant, endosseous, root-form - Product Code DZE
Product RePlant¿ Angled Abutment
Part Number 6050-52-60
Code Information Lot #50174, 39799, 49364
Recalling Firm/
Manufacturer		 Implant Direct Sybron Manufacturing, LLC
3050 E Hillcrest Dr
Westlake Village CA 91362-3171
For Additional Information Contact
818-444-3300 Ext. 3323
Manufacturer Reason
for Recall		 Issue with design specification; oversized condition.
FDA Determined
Cause 2		 Process control
Action Implant Direct sent an Urgent: Medical Device Field Corrective Action letter dated July 6, 2016, to all affected customers. The letter requests that it be reviewed and determined if customer has any affected product in inventory. Customers are asked to complete and return the Acknowledgement and Recall Return Form within 48 hours. If customers are an authorized Implant Direct Sybron Manufacturing distributor, they request that customers identify those customers that may have been shipped the affected product lot and contact these customers to inform them of this issue within fortyeight (48) hours of receipt of the notification in order to provide the customers with the correct tool. If customers have any of the affected product listed the firm will send a replacement part. If any questions contact Implant Direct Sybron Manufacturing LLC Customer Care at 1-888-649-6425.
Quantity in Commerce 205
Distribution U.S. distribution to the following; CA, WA, UT, GA, AZ, NE, OR, MI, TX, WI, FL, AL, AR, MO, VA, MA, TN, LA, NC, KS, NY, SC, OK. Foreign distribution to the following; CA, DE, IT, GB, PL, DE, GB, NL, GR, ES, HR, BG.
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.
510(K) Database 510(K)s with Product Code = DZE and Original Applicant = IMPLANT DIRECT LLC
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