FDA-Device2018-08-15Class II
Modera Modular Pedicle Screw System Shank Insertion Instrument, 3-107-07
New Era Orthopaedics, LLc
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.
Sold states
2 distributors in CO and TX.
Affected count
6 pieces
Manufactured in
1214 Research Blvd Ste 1019, N/A, Hummelstown, PA, United States
Products
Modera Modular Pedicle Screw System Shank Insertion Instrument, 3-107-07
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2604-2018Don't want to check this manually?
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