Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-2604-2018

February 13, 2017

Class II

Product summary

Firm
New Era Orthopaedics, LLc
Event
Event 80499
Status
Terminated
Classification
Class II
Quantity
6 pieces
Official record key
device-enforcement:Z-2604-2018

Official wording

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.

Code information: 11125

Distribution pattern: 2 distributors in CO and TX.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.