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 |
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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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510(K) Database | 510(K)s with Product Code = NHA
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