FDA Device recall Z-1920-2018
ImplantDirect Legacy 4 Implant, 5.7mmD x 5.7mmD Platform, Part 885708, Rx, Sterile
- FDA Device
- Class II
- terminated
- Published 2018-05-30
On 2018-05-30 the FDA classified a Class II recall of ImplantDirect Legacy 4 Implant, 5.7mmD x 5.7mmD Platform, Part 885708, Rx, Sterile by Implant Direct Sybron Manufacturing, citing the vial cap was mislabeled with the incorrect part number of 855708 but the product description on the cap was correct. The main vial label was correctly labeled.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1920-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-11-15 |
| Published | 2018-05-30 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Implant Direct Sybron Manufacturing |
| Distribution | FL, GA, MD, MI, NC, NY, OR, TX, UT, VA |
Product
ImplantDirect Legacy 4 Implant, 5.7mmD x 5.7mmD Platform, Part 885708, Rx, Sterile. The incorrect cap label shows part 855708, 5.7mmD Platform, 8mmL.
Reason
The vial cap was mislabeled with the incorrect part number of 855708 but the product description on the cap was correct. The main vial label was correctly labeled.
Identifiers
| code_info | Lot #71729 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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All Implant Direct Sybron Manufacturing recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1920-2018%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.