Recall Z-0539-2018 ยท NHA Abutment, Implant, Dental, Endosseous
Implant Direct Sybron Manufacturing, LLC
Implant Direct, INTERACTIVE HEALING COLLAR, PART NUMBER 6530-15, 5.0mmL: 3.0mmD Platform
| Date | Jan 23, 2018 |
| Status | Terminated |
| Reason | InterActive Healing Collar, Lot Number 104203, labeled as sterile with distributed prior to being sterilized. |
| Root cause | Process control |
| Action | The firm initiated their recall on 01/23/2018 by letter. the recall notices requested the following actions by the distributors: "1. Please review your inventory for the affected product. 2. Please complete and return the Acknowledgement and Recall Return Form with the affected product, if available, within 48 hours. 3. If you are an authorized Implant Direct Sybron Manufacturing 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 |
| Quantity | 55 units |
| Distribution | CO, SC, IA, NJ, FL, CA, VA, ID, Netherlands |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130572 | INTERACTIVE/ SWISHPLUS2 IMPLANT SYSTEM Implant Direct Sybron Manufacturing, LLC, Dec 24, 2013 |