| Class 2 Device Recall ImplantDirect InterActive Precision IO Scan Adapter, Part 653409PT | |
Date Initiated by Firm | November 28, 2018 |
Create Date | January 08, 2020 |
Recall Status1 |
Completed |
Recall Number | Z-0790-2020 |
Recall Event ID |
84067 |
Product Classification |
Accessories, implant, dental, endosseous - Product Code NDP
|
Product | ImplantDirect InterActive Precision IO Scan Adapter, Part #6534-09PT, Platform: 3.4mm, Non-Sterile, Rx. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. |
Code Information |
Lot numbers 104479 and 104963. |
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 | 274 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.
|
|
|
|