Recall Z-0364-2020 ยท DZE Implant, Endosseous, Root-Form
Implant Direct Sybron Manufacturing, LLC
Implant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.5mmD Platform, RxOnly, Sterile R, Made in USA Dental Implants
| Date | Nov 12, 2019 (initiated Aug 9, 2019) |
| Status | Terminated |
| Reason | A QA inspection confirmed that a Healing Collar (Part number 8735-15) was packaged instead of the Implant ordered. |
| Root cause | Packaging |
| Action | Implant Direct Sybron Manufacturing LLC mailed out an urgent medical device recall notice on 8/9/2019 to its customers via FedEx overnight priority instructing them to take the following actions: 1. Please review your inventory for the affected product. If located, 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 fortyeight (48) hours, whether you have affected product or not. 3. If you are an authorized Implant Direct Sybron Manufacturing LLC distributor, we re |
| Quantity | 23 implants |
| Distribution | U.S.: IN, VA, MD, TX, WA OUS: Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090234 | SPECTRA SYSTEM DENTAL IMPLANTS 2008 Implant Direct, LLC, May 15, 2009 |