Recall Z-2376-2018 ยท DZE Implant, Endosseous, Root-Form
Implant Direct Sybron Manufacturing, LLC
REPLANT 5.0mmD ABUTMENT, Part number 6050-52-60
| Date | May 18, 2018 |
| Status | Terminated |
| Reason | Due to out of specification, the clinician would not be able to fit and engage the abutment with the implant |
| Root cause | Process control |
| Action | On May 18, 2018, Implant Direct Sybron Manufacturing LLC issued URGENT MEDICAL DEVICE RECALL notices to their customers. Customers were advised to take the following action: 1. Inspect your inventory for the affected product. 2. Complete and return the Acknowledgement and Recall Return Form within 48 hours for Quarantine product and return products listed. 3. Please return the product and the firm will send you a replacement part. 4. Authorized Implant Direct Sybron Manufacturing distributors, the firm requests that you identify those customers that may have been shipped the affected |
| Quantity | 60 units |
| Distribution | CA, FL, GA, IL, LA, MI, MT, NC, NJ, NY, OK, OR, SC, SD, TN & WA; International: Jordan, Great Britain, Germany, Spain, Italy & Poland |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061319 | SPECTRA SYSTEM Implant Direct, LLC, Sep 29, 2006 |