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U.S. Department of Health and Human Services

Class 2 Device Recall ImplantDirect InterActive Precision IO Scan Adapter, Part 653009PT

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  Class 2 Device Recall ImplantDirect InterActive Precision IO Scan Adapter, Part 653009PT see related information
Date Initiated by Firm November 28, 2018
Create Date January 08, 2020
Recall Status1 Completed
Recall Number Z-0791-2020
Recall Event ID 84067
Product Classification Accessories, implant, dental, endosseous - Product Code NDP
Product ImplantDirect InterActive Precision IO Scan Adapter, Part #6530-09PT, Platform: 3.0mm, Non-Sterile, Rx. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
Code Information Lot numbers 104151, 106478, 114914, and 124072.
Recalling Firm/
Manufacturer		 Implant Direct Sybron Manufacturing, LLC
3050 E Hillcrest Dr
Thousand Oaks CA 91362
For Additional Information Contact Ms. Elizabeth Dunn
888-649-6425 Ext. 5467
Manufacturer Reason
for Recall		 The peek part was loose on the titanium base of the device which could result in it falling into a patient's mouth during a procedure resulting in aspiration or ingestion.
FDA Determined
Cause 2		 Process control
Action The firm first issued recall letters on 11/28/2018 via FedEx for Part number 6534-09PT and then on 12/28/2018, issued recall letters for Part number 6530-09PT via FedEx. On 2/14/2019, the firm issued another letter to their consignees that added a risk statement regarding the recall of both part numbers (6534-09PT and 6530-09PT).
Quantity in Commerce 232 devices
Distribution Distribution was made to AL, AZ, CA, FL, GA, KS, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, and VA. There was no government/military distribution. Foreign distribution was made to Canada, Armenia, Australia, Denmark, France, Germany, Great Britain, Iceland, Italy, Lithuania, Netherlands, Poland, Spain, Sweden, and Switzerland.
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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