medical Class II Updated 2018-08-15

New Era Orthopaedics, LLc recalls Modera Modular Pedicle Screw System Shank Insertion Instru

Recalled Product

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

Hazard / Issue

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.

Issued by

FDA

Affected States: CO, TX
Lot/Code Info: 11125
View official government recall

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