Recall Z-1126-2020 ยท NHA Abutment, Implant, Dental, Endosseous
Implant Direct Sybron Manufacturing LLC
SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part Number 925708
| Date | Feb 10, 2020 (initiated Jan 9, 2019) |
| Status | Terminated |
| Reason | 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 s |
| Root cause | 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 I |
| Quantity | 11 units |
| Distribution | US: None OUS: Iceland, Sweden, Spain, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081396 | SWISSPLANT DENTAL IMPLANT SYSTEM Implant Direct, LLC, Jan 14, 2009 |