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New Era Orthopaedics, LLc recalls Modera Modular Pedicle Screw System Shank Insertion Instrument, 3-107-07
Recalled August 15, 2018 · FDA recall Z-2604-2018 · New Era Orthopaedics
Hazard
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. · FDA Class II
Units
6 pieces
Sold at
2 distributors in CO and TX.
Description
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.
Product
Modera Modular Pedicle Screw System Shank Insertion Instrument, 3-107-07
Manufacturer(s)
New Era Orthopaedics, LLc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →