Recall Z-1157-2020 ยท DZE Implant, Endosseous, Root-Form
Implant Direct Sybron Manufacturing LLC
Implant Direct, CE 0086, REF: 855710, Legacy 3 Impant, Surface: SBM, Qty:1, Size:5.7mmD x 10mmL, 5.7mmD Platform, RxOnly, Sterile R,
| Date | Feb 5, 2020 (initiated Oct 11, 2019) |
| Status | Terminated |
| Reason | Through a customer complaint and and internal investigation it was determined that some implant packages contain the incorrect cover screw and extender. This could result in delay in surgery and/or a potential new surgical procedures to place the correct parts. The level of severity varies based on a one or two stage surgery. |
| Root cause | Mixed-up of materials/components |
| Action | On October 11, 2019 the firm sent an "URGENT: MEDICAL DEVICE RECALL" letter via FedEx overnight priority mail. The letter advised the consignees of the recall. In addition, the letter states: We request that you take the following actions immediately:. 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 of receipt of this notification, whether you have affected product or |
| Quantity | 78 implants |
| Distribution | US: AR, AZ, CA, ID, IL, IN, KY, MD, ND, NH, NJ, NV, NY, Oh, OR, PA, TX, UT, WA, WI, WV, GA,MO |
| 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 |