FDA Device recall Z-1157-2020
Implant Direct, CE 0086, REF: 855710, Legacy 3 Impant, Surface: SBM, Qty:1, Size:5.7mmD x 10mmL, 5.7mmD Platform, RxOnly, Sterile R
- FDA Device
- Class II
- terminated
- Published 2020-02-19
On 2020-02-19 the FDA classified a Class II recall of Implant Direct, CE 0086, REF: 855710, Legacy 3 Impant, Surface: SBM, Qty:1, Size:5.7mmD x 10mmL, 5.7mmD Platform, RxOnly, Sterile R by Implant Direct Sybron Manufacturing, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1157-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-10-11 |
| Published | 2020-02-19 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Implant Direct Sybron Manufacturing |
| Distribution | AR, AZ, CA, GA, ID, IL, IN, KY, MD, MO, ND, NH, NJ, NV, NY, OR, PA, TX, UT, WA, WI, WV |
Product
Implant Direct, CE 0086, REF: 855710, Legacy 3 Impant, Surface: SBM, Qty:1, Size:5.7mmD x 10mmL, 5.7mmD Platform, RxOnly, Sterile R,
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.
Identifiers
| code_info | Lot # 68209 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Other recalls by Implant Direct Sybron Manufacturing
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FDA Device · Class II · 2025-08-06 · Implant Direct Sybron Manufacturing - LEGACY SMARTBASE, NE 3.0D 1MML, REF: 8730-81NE
FDA Device · Class II · 2023-07-05 · Implant Direct Sybron Manufacturing - ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform
FDA Device · Class II · 2021-11-10 · Implant Direct Sybron Manufacturing - ImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD Platform
FDA Device · Class II · 2021-11-10 · Implant Direct Sybron Manufacturing - SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part Number 925708
FDA Device · Class II · 2020-02-19 · Implant Direct Sybron Manufacturing
All Implant Direct Sybron Manufacturing recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1157-2020%22
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