FDA Device recall Z-0363-2020
Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, 4.3mmD x 11.5mmL, 3.4mmD Platform, RX only, Sterile R Dental I…
- FDA Device
- Class II
- terminated
- Published 2019-11-20
On 2019-11-20 the FDA classified a Class II recall of Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, 4.3mmD x 11.5mmL, 3.4mmD Platform, RX only, Sterile R Dental I… by Implant Direct Sybron Manufacturing, citing packaging error; An internal QA inspection revealed that a incorrect healing collar could have been packaged in an implant assembly kit.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0363-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-10-26 |
| Published | 2019-11-20 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Implant Direct Sybron Manufacturing |
| Distribution | AK, AR, AZ, CA, CO, FL, ID, IL, KS, MN, NC, NV, NY, OH, TX, UT, VA |
Product
Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, 4.3mmD x 11.5mmL, 3.4mmD Platform, RX only, Sterile R Dental Implant
Reason
packaging error; An internal QA inspection revealed that a incorrect healing collar could have been packaged in an implant assembly kit.
Identifiers
| code_info | Lot numbers 120197; Exp. 07/16/2023 and 120198; Exp. 07/19/2023 |
|---|
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-0363-2020%22
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