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U.S. Department of Health and Human Services

Class 2 Device Recall Swiss Plant Dental Implant System

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  Class 2 Device Recall Swiss Plant Dental Implant System see related information
Date Initiated by Firm January 09, 2019
Date Posted February 10, 2020
Recall Status1 Terminated 3 on April 27, 2021
Recall Number Z-1126-2020
Recall Event ID 84706
510(K)Number K081396  
Product Classification Abutment, implant, dental, endosseous - Product Code NHA
Product SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part Number 925708
Code Information Lot # 109038 No affected devices distributed within the US.
Recalling Firm/
Manufacturer		 Implant Direct Sybron Manufacturing LLC
3050 E Hillcrest Dr
Westlake Village CA 91362-3171
For Additional Information Contact Elizabeth Dunn
888-649-6425 Ext. 5467
Manufacturer Reason
for Recall		 Due to a complaint received and internal investigation it was determined that implant vials were distributed with incorrect color coded vials and caps. The part/lot numbers were correct, the customer received the product they ordered, however the color on the vial label and cap labels were incorrect.Specifically, the color coded vial and cap does not match the implant size described on the vial. As a result of the incorrect color on the vial and cap, the surgeon may not be certain if the implant received was the correct size. This could result in a delay in surgery, risk of infection if the surgical site has to be closed up and a second round of anesthesia.
FDA Determined
Cause 2		 Process control
Action On 01/09/2019 the firm sent an "Urgent Field Safety Notices to all affected consignees via FedEx Overnight mail. The recall does not include any US consignees. In addition to informing consignees about the recall the notification asked customer to take the following actions: 1. Please review your inventory for the affected product. If so, please quarantine the affected product and return the product to us according to the instructions on the attached form. 2. Please complete and return the Acknowledgement Form within 48 whether you have affected product or not. 3. If you are an authorized Implant Direct Sybron Manufacturing LLC distributor, we request that you 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 this notification. 4. If you have any of the affected product listed above, please return the product and we will send you a replacement part. If you have any questions contact Implant Direct Sybron Manufacturing LLC Customer Care at 00800 4030 4030 during the hours of 8:00AM to 5:30PM ET Monday through Thursday and 8:00AM to 5PM ET on Friday. The appropriate Regulatory Agencies have been notified of this action.
Quantity in Commerce 11 units
Distribution US: None OUS: Iceland, Sweden, Spain,
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 = NHA and Original Applicant = IMPLANT DIRECT LLC
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