Recall Z-0363-2020 ยท DZE Implant, Endosseous, Root-Form
Implant Direct Sybron Manufacturing, LLC
Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, 4.3mmD x 11.5mmL, 3.4mmD Platform, RX only, Sterile R Dental Implant
| Date | Oct 26, 2018 |
| Status | Terminated |
| Reason | packaging error; An internal QA inspection revealed that a incorrect healing collar could have been packaged in an implant assembly kit. |
| Root cause | Packaging |
| Action | On 10/25/2018, a "URGENT: MEDICAL DEVICE RECALL" letter was sent to consignees via FedEx Priority overnight. The notification stated the following: 1. Please review your inventory for the affected product. 2. Please complete and return the Acknowledgement Form within 48 hours for the product listed above; Quarantine product and return product listed above. 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 wit |
| Quantity | 53 implants |
| Distribution | US distribution in the states of: CA, UT, VA, NY, IL, AR, TX, OH, NV, FL, ID, AK, NC, KS, MN, AZ, CO, |
| 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 |