FDA Device recall Z-2604-2018
Modera Modular Pedicle Screw System Shank Insertion Instrument, 3-107-07
- FDA Device
- Class II
- terminated
- Published 2018-08-15
On 2018-08-15 the FDA classified a Class II recall of Modera Modular Pedicle Screw System Shank Insertion Instrument, 3-107-07 by New Era Orthopaedics, citing this is a retrospective recall of an instrument used in spine fusion procedures with Modera Modular Pedicle Screw system implants. The firm received a customer complaint in which….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2604-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-02-13 |
| Published | 2018-08-15 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | New Era Orthopaedics |
| Distribution | CO, TX |
Product
Modera Modular Pedicle Screw System Shank Insertion Instrument, 3-107-07
Reason
This is a retrospective recall of an instrument used in spine fusion procedures with Modera Modular Pedicle Screw system implants. The firm received a customer complaint in which excessive forces were applied to the shank insertion instrument and the laser weld failed.
Identifiers
| code_info | 11125 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2604-2018%22
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