Modera Modular Pedicle Screw System Shank Insertion Instrument, 3-107-07
FDA Recall Z-2604-2018 · Posted None
Recalling FirmNew Era Orthopaedics, LLc
Recall StatusTerminated
Product CodeMNI
Date Initiated2017-02-13
Date Terminated2018-11-07
Product Quantity6 pieces
Reason for Recall
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.
Firm Action
On February 13, 2017, the firm emailed its distributors to notify them that their Rev. A devices would be replaced with Rev. B devices, and asked the distributors to mail back the Rev. A devices.
Root Cause
Device Design
Distribution Pattern
2 distributors in CO and TX.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.