Z-2604-2018Class II

Modera Modular Pedicle Screw System Shank Insertion Instrument, 3-107-07

Name: Z-2604-2018 Modera Modular Pedicle Screw System Shank Insertion Instrument, 3-107-07
Creator: New Era Orthopaedics, LLc
Published: 2017-02-13
License: https://open.fda.gov/license/

New Era Orthopaedics, LLC / initiated 2017-02-13 / Terminated / root cause: design

FDA source

New Era Orthopaedics, LLc began a recall of Modera Modular Pedicle Screw System Shank Insertion Instrument, 3-107-07 on 2017-02-13. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2604-2018
Classification: Class II
Status: Terminated
Initiated: 2017-02-13
Posted: 2018-08-03
Terminated: 2018-11-07
Recalling firm: New Era Orthopaedics, LLC
Product: Modera Modular Pedicle Screw System Shank Insertion Instrument, 3-107-07
Product code: MNI Orthosis, Spinal Pedicle Fixation
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.
Root cause tag: design
FDA root cause: Device Design
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.
Quantity in commerce: 6 pieces
Distribution: 2 distributors in CO and TX.
Product codes and lots: 11125

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2604-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2604-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-15	2018-08-03

Product code MNI

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)