Recall Z-0197-2022 ยท DZE Implant, Endosseous, Root-Form
Implant Direct Sybron Manufacturing LLC
ImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD Platform,
| Date | Sep 23, 2021 |
| Status | Open, Classified |
| Reason | Packaged dental implant contains a different size then the size declared on the labeling. |
| Root cause | Packaging change control |
| Action | On October 11, 2021, Implant Direct issued an "Urgent: Medical Device Recall" Notice via. Mail . In addition to informing consignees about the recall, the firm ask consignees to take the following actions: 1. Please immediately examine, identify, and quarantine the affected product subject to recall (Table-1). 2. If located, immediately return the affected product with the pre-paid shipping label included with the notification letter to us according to the instructions on the attached form. Upon receipt of the returned product a credit will be issued accordingly. 3. Please complete, scan, a |
| Quantity | 61 implants |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of AZ, CA, HI, IL, KS, LA, MA, MD, MI, MO, MT, NE, NJ, NY, OH, OR, PA, RI, SC, TX, UT, VA, WA, WI and the country of Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K192221 | Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture-mounts Implant Direct Sybron Manufacturing, LLC, Jun 25, 2020 |