Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Modera Modular Pedicle Screw System Shank Insertion Instrument Recalled by New Era Orthopaedics, LLc Due to This is a retrospective recall of an instrument...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact New Era Orthopaedics, LLc directly.
Affected Products
Modera Modular Pedicle Screw System Shank Insertion Instrument, 3-107-07
Quantity: 6 pieces
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 2 states: CO, TX
About New Era Orthopaedics, LLc
New Era Orthopaedics, LLc has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report