FDA Device recall Z-0010-2020
ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile
- FDA Device
- Class II
- terminated
- Published 2019-10-09
On 2019-10-09 the FDA classified a Class II recall of ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile by Implant Direct Sybron Manufacturing, citing the incorrect device was packaged in the vial.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0010-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-08-07 |
| Published | 2019-10-09 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Implant Direct Sybron Manufacturing |
| Distribution | AL, AZ, CA, CO, CT, FL, GA, ID, IL, KY, MA, MD, NM, NV, NY, PA, TX |
Product
ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
Reason
The incorrect device was packaged in the vial.
Identifiers
| code_info | Lot 108191, UDI (01)10841307108313(17)230118(10)108191 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0010-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.